Highlander™ 014 PTA Balloon Dilatation Catheter

Safety and Risk Information

Indication for Use

The Highlander™ 014 PTA Balloon Dilatation Catheter is indicated for use in percutaneous transluminal angioplasty (PTA) of the peripheral vasculature, including femoral, popliteal, infra-popliteal, and renal arteries. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

Contraindications

None known.

Warnings

1. Contents supplied STERILE using ethylene oxide (EO). Non-pyrogenic. Do not use if sterile barrier is open or damaged, or contamination is evident. Do not reuse, reprocess, or resterilize.

2. This device has been designed for single patient use. 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. Additionally, re-use and/or repackaging may compromise the structural integrity and/or material and design characteristics of the device, which may lead to device failure, and/or lead to patient injury.

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. To reduce the potential for vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis.

5. To reduce the potential for stent or stent graft damage and/or vessel damage from the stent or stent graft, the diameter of the balloon should be no greater than the diameter of the stent or stent graft. Refer to the stent or stent graft IFU for safety information including the WARNINGS, PRECAUTIONS, and potential ADVERSE EFFECTS regarding the use of balloon post-dilatation.

6. When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated. 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 balloon separation.

7. Do not exceed the RBP (Rated Burst Pressure) recommended for this device. Balloon rupture may occur if the RBP rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended.

8. After contact with blood or use, this product is a biohazard. Handle and dispose as a biohazard in accordance with acceptable medical practices and applicable local, state, and federal laws and regulations.

9. The safety and effectiveness of the device has not been established, or is unknown, in vascular regions other than those specifically indicated.

Precautions

1. Refer to accessory IFU for potential access site warnings, precautions, and adverse events.

2. 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.

3. The Highlander™ 014 PTA Balloon Dilatation Catheters shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty.

4. The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the PTA catheter through a smaller size introducer sheath than indicated on the label.

5. Do not remove the guidewire in situ to shoot contrast through the wire lumen or perform a wire exchange. If the wire is removed while the balloon catheter is situated in tortuous anatomy, the risk of kinking the catheter is increased.

6. Use the recommended balloon inflation medium (25% contrast medium/75% sterile saline solution). It has been shown that a 25%/75% contrast/saline ratio has yielded faster balloon inflation/deflation times. Never use air or other gaseous medium to inflate the balloon.

7. If resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy. If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.

8. If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit, and replace the previously used balloon catheter with a new balloon. Exercise caution when removing the device.

9. Do not continue to use the balloon catheter if the shaft has been bent or kinked. Do not excessively bend, twist, or alter the shape of the device as it may compromise the integrity of the coating.

10. Prior to re-insertion through the introducer sheath, the balloon should be wiped clean with wet gauze and rinsed with sterile normal saline. Avoid excessively wiping the coated portions of the device, or wiping with dry gauze, as this may damage the coating.

11. Balloon re-wrapping should only occur while the balloon catheter is supported with a guidewire or stylet.

12. This device is coated with a silicone-based, hydrophobic coating at the distal segment of the shaft and the balloon. Please refer to the Directions for Use section for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the coating, which may require intervention or result in serious adverse events.

13. The 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 balloon deployment.

14. Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.

15. Avoid pre-soaking devices for extended periods, as this may impact the coating performance.

16. It is recommended to consider the use of anti-coagulants, anti-platelet agents, and/or vasodilators in conformance with the accepted standard of practice or institutional guidelines surrounding peripheral endovascular procedures.

Potential Complications

The complications which may result from a peripheral balloon dilatation procedure include:

• Additional invasive surgery • Additional non-invasive surgery • Air Embolism • Aneurysm, pseudoaneurysm • Arrhythmias • Excessive or uncontrollable amount of bleeding due to vessel or tissue injury/trauma • Foreign body embolism • Hematoma • Hemorrhage, bleeding • Hemothorax • High blood pressure/hypertension • Hypersensitivity, allergic reaction • Infection • Inflammation • Low blood pressure/hypotension • Pain • Perforation of vessels • Peripheral Arterial Occlusion – renal or limb • Peripheral Arterial Thrombosis – renal or limb • Peripheral Arterial Ischemia • Pneumothorax • Prolonged surgery • Shock • Stroke/CVA • Vessel dissection • Vessel spasm

Please consult product labels and instructions for use for indications, contraindications, hazards, warnings, and precautions.

BD, the BD logo, and Highlander are trademarks of Becton, Dickinson and Company or its affiliates. © 2023 BD. All rights reserved. Bard Peripheral Vascular, Inc. | 1 800 321 4254 | www.bd.com | 1625 W. 3rd Street Tempe, AZ 85281

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