Indications for Use
The VASCUTRAK® PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arterioveneous
dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature.
Contraindications
The VASCUTRAK® PTA Catheter is contraindicated:
• where there is the inability to cross the target lesion with a guidewire
• for use in the coronary or neuro vasculature
Warnings
1. Contents supplied STERILE using ethylene oxide (EO). Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Do not reuse, reprocess or re-sterilize. Use the catheter prior to the “Use By” date specified on the package label.
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.
To reduce the potential for vessel damage or difficulty in deflating, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis
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 VASCUTRAK® PTA Balloon Dilatation Catheter should only be used by physicians experienced in the performance of percutaneous transluminal angioplasty.
3. In order to activate the hydrophilic coating, wet the VASCUTRAK® balloon and catheter with sterile saline or wipe the balloon catheter with sterile saline saturated gauze immediately prior to its insertion in the body. Do not wipe the balloon catheter with dry gauze.
4. When back loading the catheter onto the guidewire, support the catheter and ensure that the guidewire tip does not snag or come into contact with the balloon.
5. 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.
6. Use the recommended balloon inflation medium (50% contrast medium/50% 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. VASCUTRAK® PTA Dilatation Catheters should be used with caution for procedures involving calcified lesions, stents or synthetic vascular grafts due to the abrasive nature of these lesions.
8. Never attempt to move the guidewire when the balloon is inflated.
9. Fully evacuate the balloon prior to withdrawing the system. Larger sizes of VASCUTRAK® Balloons may exhibit slower deflation times. If the balloon does not deflate, advance a sheath or catheter over the proximal portion of the balloon to straighten out the transition from connection of the balloon to the inflation lumen.
10. If resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast medium 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.
11. 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.
12. Do not continue to use the balloon catheter if the shaft has been bent or kinked.
Prior to re-insertion through the introducer sheath, re-activate the hydrophilic coating and clean the balloon catheter by wiping the balloon catheter with sterile saline saturated gauze and rinsing
