Instructions for Use - AGILTRAC .035 Peripheral Dilatation Catheter
Indications, Contraindications, Warnings, Precautions, Adverse Events
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Indications
The AGILTRAC™ .035 Peripheral Dilatation Catheter is intended:
- To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries).
- For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Contraindications
None known for this device.
Warnings
The AGILTRAC™ .035 Peripheral Dilatation Catheter is not intended for use in the coronary arteries.
This device is not recommended for stent delivery.
This device is intended for single use only. Do not resterilize and/or reuse it, as this can compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing.
To reduce the potential for vessel damage the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis in percutaneous transluminal angioplasty (PTA). For use in an endovascular prosthesis system, the balloon should be inflated only to the size of the vessel profile.
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 under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding.
Balloon pressure should not exceed the rated burst pressure (RBP). Refer to the product label for device specific information. The rated burst pressure (RBP) is based on results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their RBP. To prevent over-pressurization, use a pressure-monitoring device.
Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
Note the product "Use By" date specified on the package.
Do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead, prepare a new catheter.
Precautions
A thorough understanding of the principles, clinical applications and risks associated with PTA is necessary before using this product.
NOTE: Refer to the Instructions for Use contained within the endovascular prosthesis system used for specific information regarding graft implantations and the use of a peripheral dilatation catheter within the iliac attachment systems.
Any use for procedures other than those indicated in these instructions is not recommended.
This device is not recommended for applications that may require inflation higher than those recommended for this catheter.
Do not use if package is open or damaged.
Prior to use, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.
During the procedure, appropriate anti-coagulant therapy must be provided to the patient as needed. Anti-coagulant therapy should be continued for a period of time to be determined by the physician after the procedure.
Adverse Events
Potential adverse events include but are not limited to:
- Air embolization
- Aneurysm
- Arteriovenous fistula
- Hematoma at puncture site
- Thrombus
- Vessel perforation or dissection
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