Advancing Lives and the Delivery of Health Care™

INTRALUMINAL CROSSINGVIA ATHERECTOMY

Anatomy of a CTO

CROSSER®

CTO RECANALIZATION CATHETER

SIDEKICK®

SUPPORT CATHETER

PROXIMAL CAP

HIDDEN COLLATERAL

CALCIFIC PLANE

MID-OCCLUSION

DISTAL CAP

CTO Crossing involves passage of three segments:

· Proximal Cap

· Mid-Occlusion

· Distal Cap

ANGLED TIP OF SUPPORT CATHETER ALLOWS FOR IMPROVED STEERABILITY TOWARDS FLUSH OCCLUSIONS OR LESIONS ON AN ANGLE

Demonstrated Successin the PATRIOT Clinical Study6

The Challenge· 100% of lesions were resistant to conventional guidewire techniques

· 75% of lesions were calcified

· 55.7% of lesions had complex CTO morphology

Challenge Accepted· 83.5% success of complete lesion crossing

· Zero CROSSER® related clinical perforations

· 2 minutes, 6 seconds average device activation time

Challenges of a CTO

· CTO procedure failures are primarily due to the inability to:1

· Penetrate proximal cap

· Navigate side branches

· Re-enter distal true lumen

· Failure to cross lesions, with possible procedure failure, may lead to important burdens such as lengthy procedures, increased radiation exposure, periprocedural complications, and repeat intervention2,3

· Clinical literature has shown CTO crossing success rates of 5% to 66% with primary wire-catheter1

· This may result in sub-intimal deflection and subsequent dissection which may impair and isolate new lumen from collateral circulation4,5

ZEROCROSSER®

RELATED CLINICAL PERFORATIONS

5-66%CROSSING SUCCESS WITH PRIMARY WIRE-CATHETER1

83.5%CROSSING SUCCESS WITH CROSSER®

2 MIN.6 SECONDSACTIVATION TIME

LENGTHY PROCEDURES

PERIPROCEDURAL COMPLICATIONS

RADIATION EXPOSURE

REPEATINTERVENTION

CONVENTIONALGUIDEWIRE CROSSING

CROSSING VIA ATHERECTOMY

Focused Efficiency for Highly Calcified Lesions

The Workhorse 5F Catheter The CROSSER® 14S Catheter is a frontline therapy that enables central lumen crossing and maximizes therapeutic options for CTO recanalization via atherectomy.

The small CROSSER® S6 Catheter tip focuses vibrational energy providing greater efficiency. The flexible design of the CROSSER® S6 Catheter facilitates deliverability to small and tortuous vessels.

CROSS CHALLENGING LESIONS VIA ATHERECTOMY

The performance of the CROSSER® Catheter is optimized by precise activation and saline delivery. The integrated saline injector has pre-set settings for a flow rate of 18ml/min and can be operated by one person for added convenience.

Foot Switch

IV Pole

150 ML STERILE DISPOSABLE SYRINGE

FLUID ADMINISTRATION SET

84" TUBING

STOPCOCK

NOT INCLUDED

INCLUDED WITH CROSSER® GENERATOR

The reusable, 21kHz CROSSER® Generator converts AC power into high frequency current. Piezoelectric crystals within the transducer convert high frequency current into vibrational energy. The physician controls the procedure and pace of the CROSSER® Generator and FLOWMATE® Injector with a single foot switch.

Generator

Injector

Capital Equipment

* Data on file.

Support Catheter Features

• Stainless steel, braided shaft construction enables greater push and torquability*

• Angled tip allows for improved steerability towards flush occlusions or lesions on an angle

The various tip stiffness levels of the PORTER® Delivery Guidewire provide precise steerability with 1:1 torque transmission. The unique hydrophilic coating of the PORTER® Guidewire provides enhanced trackability in tortuous anatomy.

The SEEKER® Crossing Support Catheter expands treatment possibilities by combining optimal pushability with its low tip entry profile and unmatched radiopaque marking system for lesion length measurement capabilities.*

3

9

6

GRAM FORCEOFFERING

12

.014" .018" .035"

EACH BLACK AND WHITE MARKER IS 1 CM

DOUBLE MARKERS DELINEATE THE 10 CM AND 20 CM LENGTHS

STRAIGHT ANGLED STRAIGHT TAPERED ANGLED TAPERED

More Options

Disposable Devices

CROSS, MEASURE, REDUCE RADIATION EXPOSURE**

Enhance Your Procedurewith the GeoAlign® Marking System*

CROSSER® + GeoAlign®

CTO Recanalization System Marking System

The GeoAlign® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. These markings are designed for simplified length measurement between two intravascular points. During repeat catheter placement, the GeoAlign® Marking System is designed to help increase procedure efficiency and reduce radiation exposure by minimizing fluoroscopy time.

DISTANCE FROM THE DISTAL TIP OF CATHETER

MARKER BANDS DENOTED EVERY 1 CM

DESIGNED TO

SIMPLIFYINTRAVASCULAR MEASUREMENT

DESIGNED TO

INCREASEPROCEDUREEFFICIENCY

DESIGNED TO

REDUCERADIATIONEXPOSURE**

* The GeoAlign® Marking System provides an approximation that may not be an exact representation of the distance traveled intravascularly and should be confirmed under fluoroscopy.** The GeoAlign® Marking System was evaluated in an animal study (repeat PTA in swine artery) to show a reduction in fluoroscopy time. The study was performed by 3 physicians who tested the LUTONIX® 035 DCB (no drug) and the ULTRAVERSE® 035

PTA Catheter, both with the GeoAlign® Marking System, to POBA with no GeoAlign® markings (n=112, test n=96 (with an average placement time of 66 seconds), control n=16 (with an average placement of 90 seconds)). Animal data on file. Animal test results may not be indicative of clinical performance. Different test methods may yield different results

PHYSICIANS SIGNATURE

CONTACT PHONE NO.

REPRESENTATIVE NAME

Ordering Information

Catheters & Capital Equipment Adjunctive Devices

1 Banerjee, S., et al. Comparative Assessment of Guidewire and Microcatheter vs a Crossing Device-Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions. Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists (2015).

2 Javed, U. & Laird, J.R. Specialty crossing devices: Understanding the learning curve. Endovascular Today, 52-57 (2012).

3 Singh, G.D., et al. Endovascular recanalization of infrapopliteal occlusions in patients with critical limb ischemia. Journal of vascular surgery 59, 1300-1307 (2014).

CROSSER® CTO Recanalization CathetersDescription Length (cm) Platform Product Code

CROSSER® Catheter 14S

106RX CRUS106

OTW CRUOS106

146RX CRU14SA

OTW CRUO14SA

CROSSER® Catheter S6

106 no wire CRUS6106154 no wire CRUS6A

CROSSER® Generator / FLOWMATE® InjectorDescription Product Code

CROSSER® Generator GEN200FLOWMATE® Injector INJ100FLOWMATE® Procedural Kit (5/box) INJKIT

FLOWMATE® Injector is intended for use with the CROSSER® Generator

Atherectomy Reimbursement Information*

Abbreviated Partial Description CodeAtherectomy with or without Angioplasty** Femoral/Popliteal Artery 37225

Stent and Atherectomy with or without Angioplasty**

Femoral/Popliteal Artery 37227

Atherectomy with or without Angioplasty** Tibial/Peroneal Artery 37229

Catheter, transluminal atherectomy, directional C1714* C. R. Bard, Inc. does not guarantee that the procedures described herein will be reimbursable in whole, or in part,

by any public or private payer, including Medicare. C. R. Bard, Inc. specifically excludes any representation or warranty relating to reimbursement.CPT codes copyright 2015 American Medical Association. All Rights Reserved

** See Bard Reimbursement Guide for full procedural CPT Codes

PORTER® Guidewires (5/box)Wire Size Length (cm) Tip Stiffness Product Code

.014”

1953 g GWP14036 g GWP1406

300

3 g GWP1403X6 g GWP1406X9 g GWP1049X12 g GWP1412X

SIDEKICK® Support CathetersLength (cm) Shape Product Code

70

Straight SD70GStraight Tapered SD70TG

Angled SD70AGAngled Tapered SD70ATG

110

Straight SD110GStraight Tapered SD110TG

Angled SD110AGAngled Tapered SD110ATG

For use with CROSSER® Peripheral CTO Recanalization Catheters 14S

SEEKER® Crossing Support Catheters (5/box)Guidewire Length (cm) Product Code

.014"135 SK13514150 SK15014

.018”90 SK9018

135 SK13518150 SK15018

.035”

65 SK6535M90 SK9035M

135 SK13535M150 SK15035M

USHER® Support CathetersLength (cm) Shape Product Code

83Tapered USH83TG

Angled Tapered USH83ATG

130Tapered USH130TG

Angled Tapered USH130ATGFor use with CROSSER® Peripheral CTO Recanalization Catheters S6

4 Cannon, L. & Patel, S. Novel high-frequency vibration approach for recanalization of difficult coronary and peripheral chronic total occlusions. Interv Cardiol 2, 281-288 (2010).

5 Torey, J., PA-C & Davis, T. Using IVUS to guide intraluminal crossing of CTOs. Supplement to Endovascular Today (2014).

6 Laird, J., et al. Recanalization of infrainguinal chronic total occlusions with the crosser system: results of the PATRIOT trial. J Invasive Cardiol 26, 497-504 (2014).

CROSSER® CTO Recanalization CatheterIndications: The CROSSER® Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The CROSSER® Catheter is only intended for use with the CROSSER® Generator. Refer to the CROSSER® Generator Manual of Operations for proper use.Contraindications: The device is contraindicated for use in carotid arteries.Warnings and Precautions: 1) The CROSSER® Recanalization System should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA). 2) Prior to use, the packaging and product should be inspected for signs of damage. Never use damaged product or product from a damaged package. 3) DO NOT activate the CROSSER® Recanalization System without proper irrigation. Make sure to establish proper irrigation prior to introduction into guide catheter. Always use REFRIGERATED SALINE. 4) The CROSSER® Recanalization System should be used in conjunction with proper anticoagulation agents. 5) When exposed to the vascular system, never advance or withdraw the CROSSER® Catheter without proper fluoroscopic guidance. 6) It is not recommended to use the CROSSER® Catheter over wires which have polymer-jacketed distal ends. 7) Do not exceed 5 minutes of activation time as CROSSER® Catheter malfunction may occur. If 5 minutes of activation time is achieved exchange for a second CROSSER® Catheter before resetting the CROSSER® Generator. 8) When using the CROSSER® Catheter 14S with the SIDEKICK® or MICROSHEATH® XL Support Catheter Tapered, the CROSSER® Catheter can be advanced approximately 15 cm from the tip of the support catheter before resistance is encountered due to the taper on the CROSSER® Catheter aligning with the taper on the support catheter. A taper lock-up marker (single black marker on the CROSSER® Catheter shaft) is located 127 cm from the distal tip for the 146 cm CROSSER® Catheter and 87 cm from the distal tip for the 106 cm CROSSER® Catheter. The taper lock-up marker can be used as an indicator that the tapers on the catheters are nearing alignment; advance the CROSSER® Catheter slowly. Do not continue to advance the CROSSER® Catheter if resistance is encountered. 9) When manipulating the CROSSER® Catheter, the Catheter shaft may become warm to the touch. A warm feeling is normal, however, if the Catheter shaft becomes hot discontinue use immediately and withdraw from patient. Once removed from the patient confirm that irrigation is flowing. 10) When using the CROSSER® Catheter in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the CROSSER® Catheter tip. Kinking or prolapse of the tip could cause catheter breakage and/or malfunction. 11) Position Foot Switch and cable to minimize potential tripping hazard. 12) Ensure CROSSER® Generator is securely mounted to IV pole to reduce risk of falling. 13) Should high frequency vibration fail to stop when foot switch is released, power off CROSSER® Generator or unplug from power receptacle. 14) Never activate the CROSSER® Generator without a CROSSER® Catheter attached to the Transducer. 15) Store in a cool, dry, dark place. Rotate inventory so that the catheters and other dated products are used prior to the “Use By” date. 16) This device has been designed for single use only. Reusing this medical device bears with it the risk of cross-patient contamination as medical devices - particularly those with long and small lumina, joints, and/or crevices between components - are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for and indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or mircroorganisms which may lead to infectious complications. 17) Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes. 18) After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations. 19) GeoAlign® Marking System is designed to be used as an additional reference tool to accompany the interventionalist standard operation procedure. The use of fluoroscopic imaging is recommended following positioning of the catheter of the target lesion and prior to device activation.Potential Adverse Events: As with most percutaneous interventions, potential adverse effects include: Bleeding which may require transfusion or surgical intervention • Hematoma • Perforation • Dissection • Guidewire entrapment and/or fracture • Hypertension • Hypotension • Infection or fever • Allergic reaction • Pseudoaneurysm or fistula Aneurysm • Acute reclosure • Thrombosis • Ischemic events • Distal embolization • Excessive contrast load resulting in renal insufficiency or failure • Excessive exposure to radiation • Stroke/CVA • Restenosis • Repeat catheterization / angioplasty • Peripheral artery bypass • Amputation • Death or other bleeding complications at access site.CROSSER® GeneratorIndications: The CROSSER® Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions. The CROSSER® Generator is intended for use only with the CROSSER® Catheter. Refer to the CROSSER® Catheter Instructions for Use.Warnings and Precautions: 1) The CROSSER® Recanalization System should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA). 2) Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 3) Warning: No modification of this equipment is allowed. 4) Warning: Risk of injury or death to operator or patient can result from unauthorized modification to CROSSER® Generator. 5) Note: Position CROSSER® Generator to allow easy access to separable power cord during use. 6) Prior to use, the CROSSER® Generator, Foot Switch and Transducer should be inspected for signs of damage. Never use damaged components. Contact manufacturer for a replacement. 7) The CROSSER® Generator is not protected against the ingress of fluids (IPX0). Do not place fluids above or on the CROSSER® Generator as damage to the CROSSER® Generator or shock may result. 8) Explosion Hazard: Do not use in the presence of flammable anesthetics. 9) Electrical Shock Hazard: Do not attempt to service CROSSER® Generator, Foot Switch or Transducer. Contact manufacturer for servicing requirements. 10) In the event of a power outage, power interruption, or system reset, replace CROSSER® Catheter before restarting recanalization procedure. 11) This device generates, uses, and can radiate radio frequency energy and should

only be used and installed according to these instructions for use. 12) DO NOT activate the CROSSER® Recanalization System without proper irrigation. Make sure to establish proper irrigation prior to introduction into guide catheter. 13) Do not exceed 5 minutes of activation time as CROSSER® Catheter malfunction may occur. If the 5 minutes of activation time is achieved, exchange the device for a new CROSSER® Catheter before resetting the CROSSER® Generator. 14) Position Foot Switch and cable to minimize potential tripping hazard. 15) Ensure CROSSER® Generator is securely mounted to a 5 caster IV pole with minimum caster diameter of 7.62 cm (3 inches) and a minimum base diameter of 55.9 cm (22 inches) no higher than 1.5 meters off the ground. 16) Should high frequency vibration fail to stop when Foot Switch is released, power CROSSER® Generator ‘OFF’ or unplug from power receptacle. 17) Keep out of reach of patients. The CROSSER® Generator must be at least 1.5 meters away from the patient. Caution! The unit is equipped with an exhaust vent. Do not block the openings or internal heat build-up may occur, causing heat build-up or damage to the equipment.FLOWMATE® InjectorIndications: The FLOWMATE® Injector is indicated for use as a sterile saline injector for use as an accessory to the CROSSER® Recanalization System. Refer to the CROSSER® Generator and the CROSSER® Catheter Instructions for Use for complete system operation and interventional use procedure.Warnings and Precautions: 1) The FLOWMATE® Injector should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA). 2) Prior to use, the FLOWMATE® Injector, Foot Switch and all connection to power and the CROSSER® Generator should be inspected for signs of damage. Never use damaged components. Contact the manufacturer for a replacement or servicing. 3) The FLOWMATE® Injector is intended to be used with sterile normal saline only. Do not use the FLOWMATE® Injector with contrast media. 4) Explosion Hazard: Do not use in the presence of flammable anesthetics. 5) Electrical Shock Hazard: Do not attempt to service FLOWMATE® Injector or Foot Switch. Contact manufacturer for servicing requirements. 6) The Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked Hospital Only or Hospital Grade. Grounding reliability cannot be achieved by connecting the system to a Multiple Portable Socket-Outlets (MPSO – power strip) or extension cord. 7) In the event of a power outage or power interruption, run through the set-up procedures. The FLOWMATE® Injector is designed to prevent operation following such events until the set-up procedures are repeated. 8) This FLOWMATE® Injector generates, uses, and can radiate radio frequency energy and should only be used and installed according to these instructions for use. 9) Position Foot Switch and cable to minimize potential tripping hazard. 10) Ensure FLOWMATE® Injector is securely mounted to a 5 caster IV pole no higher than 1.3 meters (51 inches) off the ground. The FLOWMATE® Injector should not be mounted above the CROSSER® Generator. 11) Should high frequency vibration or saline infusion fail to stop when Foot Switch is released, power FLOWMATE® Injector/ CROSSER® Generator ‘OFF’ or unplug from power receptacle. 12) Do not reuse disposable items. Dispose of per normal hospital procedures. 13) Air Embolism Risk: to minimize air embolism risk, make certain the operator is trained on proper syringe loading techniques. Before injecting, be sure to clear air trapped in the syringe, infusion line and the CROSSER® Catheter. Do not introduce the CROSSER® Catheter into the patient until all air has been purged from the infusion line and the CROSSER® Catheter. A steady stream of saline exiting from the tip of the CROSSER® Catheter will be observed once all air has been purged.PORTER® GuidewireIndications: The PORTER® Guidewires are intended for use in the coronary and peripheral vasculature.Contraindications: The PORTER® Guidewire is not intended for use in the cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PCI).Precautions: Failure to follow the instructions may compromise guidewire performance and result in complications. Prior to use, confirm compatibility of guidewire outer diameter with the balloon catheter. The tip section of the guidewire has a proper orientation for shaping. Identify the flexing plane before shaping. Shape in the same plane as that for flexure. Guidewire advancement, withdrawal, and torquing should be monitored by fluoroscopy. These guidewires have stiff distal ends. Therefore the risk of perforation or injury when using these wires is higher. These wires must be operated carefully. Use the most flexible guidewire that will treat the lesion i.e. the guidewire with the smallest flexibility number and take due care to minimize the risk of perforation or other damage to the blood vessels.Warning: A guidewire is a delicate instrument and must not be advanced, withdrawn, or torqued if resistance is met. Guidewire manipulations must always be observed under fluoroscopy. If the guidewire is removed and is to be re-inserted, it must be inspected for signs of damage (weakened or kinked segments) prior to re-introduction. Do not re-introduce if guidewire is weakened or kinked.SEEKER

® Crossing Support CatheterIndications for Use: The SEEKER

® Crossing Support Catheters are recommended for guidewire exchange and infusion devices designed for use in the peripheral vascular system. The catheters are intended to support a guidewire during access into the vasculature, allow for guidewire exchanges, and provide a passage for delivery of saline solutions and/or diagnostic contrast agents. Contraindications: None known.Warnings: 1) Contents supplied STERILE using ethylene oxide (EO). Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Single patient use only. Do not reuse, reprocess or resterilize. 2) This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. 3) Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or

mechanical changes. 4) When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. 5) While retracting the catheter, if resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip breakage or catheter separation. 6) After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations. 7) Exceeding the maximum injection pressure of 300 psi may result in catheter failure.Precautions: 1) Carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. 2) The SEEKER

® Crossing Support Catheter shall only be used by physicians trained in the use of vascular diagnostic catheters. 3) The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the crossing support catheter through a smaller size introducer sheath than indicated on the label. 4) Only use guidewires of the recommended diameter as noted on the packaging. 5) Flush catheter with sterile saline until saline is seen exiting distal tip. 6) If resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the catheter, introducer sheath and guidewire (as necessary) as a single unit. 7) Do not continue to use the catheter if the shaft has been kinked. 8) Prior to re-insertion through the introducer sheath, wipe the catheter clean with wet gauze, flush with sterile saline, and check the tip for damage and kinking. 9) Rotate inventory so that the catheters and other dated products are used prior to the “Use By” date. 10) If the catheter is to be used as an infusion catheter, reference Table 2 to ensure proper infusion rates/pressures are utilized and not exceeded.Potential Adverse Reactions: The complications which may result from a crossing support catheter procedure include: • Vessel dissection, perforation, rupture or total occlusion • Embolism • Hypotension/hypertension • Hemorrhage or hematoma • Infection • Vessel Spasm • Distal embolization of thrombotic or atherosclerotic material • DeathSIDEKICK® and USHER® Support CathetersIndications: The SIDEKICK® and USHER® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.Contraindications: The SIDEKICK® and USHER® Catheters are contraindicated for use with cutting/scoring balloons, pediatrics, neonatal and neurovascular patients.Warnings: 1) Contents are supplied STERILE, using ethylene oxide (EO), and Non Pyrogenic. Do not use if sterile barrier is opened or damaged. 2) This device has been designed for single patient use only. Reusing this medical device bears the risk of cross patient contamination as medical devices, particularly those with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. 3) Do not reuse, reprocess or resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes. 4) When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Movement of the product without fluoroscopic guidance may result in damage to the product or vasculature or cause vessel perforation. 5) Manipulating or torquing a product against resistance may cause damage to the product or vasculature or cause vessel perforation. Never advance, withdraw or torque a catheter which meets resistance. 6) Flush the catheter prior to inserting and reinserting the product to prevent air from entering catheter system. 7) After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations. 8) Diethylhexylphthalate (DEHP) is a plasticizer used in some polyvinyl chloride medical devices. DEHP has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy. Although the toxic and carcinogenic effects of DEHP have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial. Bard has not assessed any related adverse effects in relation to the exposure to DEHP with neonates, infants, pregnant or breast feeding women. It is the responsibility of the physician to assess risks associated with the use of a device containing DEHP.Precautions: 1) Carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. 2) The SIDEKICK® and USHER® Catheters should only be used by physicians trained in percutaneous intravascular techniques and procedures. 3) Verify compatibility of the product’s inner and outer diameters and lengths with other devices before use. 4) Refer to package label for tip shape for the SIDEKICK® and USHER® Catheters. Do not attempt to manipulate or re shape the tip configurations. 5) When using a Rotating Hemostatic Valve (RHV) in place of the hemostatic valve provided with the product, do not over tighten the RHV. A tight RHV may damage the CROSSER® Catheter. Use extra caution when using a self sealing RHV. 6) Flushing through the sideport of the hemostatic valve is not recommended when the CROSSER® Catheter is in place as the infusate may leak from the hemostatic valve. 7) GeoAlign® Marking System is designed to be used as an additional reference tool to accompany the interventionalist standard operation procedure. The use of fluoroscopic imaging is recommended following positioning of the catheter to the target lesion and prior to device activation.Adverse Effects: Use of the SIDEKICK® and USHER® catheters may give rise to the following complications: • Hemorrhage, Hematoma, Ischemia • Vessel perforation/dissection • Allergic reaction to contrast medium • Vascular occlusion, thrombosis • Infection • Vessel erosion, spasms • Embolism • Puncture site hematoma, pain and tenderness.

Please consult package inserts for more detailed safety information and instructions for use.

Bard, Advancing Lives and the Delivery of Health Care, Crosser, Flowmate, GeoAlign, Porter, Seeker, Sidekick and Usher are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. All other trademarks are the property of their respective owners. Copyright © 2017, C. R. Bard, Inc. All Rights Reserved. Illustrations by Mike Austin. Copyright © 2017.

All Rights Reserved. Bard Peripheral Vascular Inc. | 1 800 321 4254 | www.bardpv.com | 1625 W. 3rd Street Tempe, AZ 85281 BPV/CTTO/0416/0010(1)