Prescriptive Information
Untitled Document
Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
Indications
The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Contraindications
None known.
Warnings
- 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.
- 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.
- Do not exceed the rated balloon burst pressure. Use only the recommended balloon inflation medium.
- Never use air or any gaseous medium to inflate the balloon.
This product contains no detectable latex.
Potential Adverse Effects
The complications that may result from a balloon dilatation procedure include:
- Abrupt closure
- Acute myocardial infarction
- Acute or subacute thrombosis
- Additional intervention required (major, moderate)
- Allergic reaction (device, contrast medium and medications)
- Amputation
- Aneurysm
- Angina
- Arrhythmias (major, minor), including ventricular fibrillation
- Arteriovenous fistula
- Coma
- Death
- Embolization, which includes thromboembolization (arterial, pulmonary)
- Hematoma
- Hemmorrhage, including bleeding at puncture site
- Hypotension/Hypertension
- Inflammation
- Intimal tear
- Ischemia, including tissue ischemia, steal syndrome and necrosis
- Neurological events, including peripheral nerve injury and neuropathies
- Occlusion
- Organ failure (single, multiple)
- Paralysis
- Pseudoaneurysm
- Pyrogenic reaction
- Renal failure
- Restenosis
- Seizures
- Sepsis/infection
- Shock
- Stroke
- Transient ischemic attack
- Vessel dissection, perforation, rupture or spasm
- Weakness
Cautions
- Care should be taken to control the position of the guide catheter tip during manipulation of the balloon catheter.
- Distal protection is strongly recommended when using the Sterling Monorail PTA Balloon Dilatation Catheter in a carotid angioplasty procedure.
- If a distal protection device is used, follow the manufacturer's instructions for use.
- Any use for procedures other than those indicated in these instructions is not recommended.
- 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.
- The Sterling Monorail PTA Balloon Dilatation Catheter should be used with caution for procedures involving calcified lesions or synthetic vascular grafts due to the abrasive nature of these lesions.
- The Sterling Monorail PTA Balloon Dilatation Catheters are not intended for injection of contrast medium.
- If resistance is met during post procedure withdrawal of the catheter, it is recommended to extract the entire system with the guide catheter.
- Precautions to prevent or reduce clotting should be taken when any catheter is used.
- The Sterling Monorail PTA Balloon Dilatation Catheter is a non-pyrogenic device.
- To minimize the possible introduction of air into the system, it is imperative that prior to proceeding, careful attention is paid to the maintenance of tight catheter connections and thorough aspiration and flushing of the system.
- Never advance the angioplasty catheter without the guidewire extending from the tip.
- Do not pull the Balloon Protector proximally on to the catheter shaft.
Trademark
Sterling is a trademark of Boston Scientific or its affiliates.
Pebax is a registered trademark of Arkema Corp.
