The SABER® PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilation of balloon- expandable and self-expanding stents in the peripheral vasculature.
- None known for PTA procedure.
- The SABER® PTA Balloon Dilatation catheter is contraindicated for use in coronary arteries.
- For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may increase the risk of inappropriate resterilization and cross contamination and compromise the structural integrity of the device and/or lead to device failure, which in turn, may result in patient injury, illness or death.
- Exposure to temperatures above 54°C (130°F) may damage the device.
- Do not expose the device to organic solvents (e.g. alcohol).
- Do not use Ethiodol or Lipiodol* contrast media.
- Store in a cool, dark, dry place.
- Use the catheter prior to the “Use By” date specified on the package.
- Do not use if inner package is opened or damaged.
- Prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used. Do not use if product damage is suspected or evident.
- To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion. The balloon dimensions are printed on the product label. The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.
- Do not exceed the rated burst pressure recommended on the label. The rated burst pressure is based on the results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over-pressurization.
- Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath. Balloon rupture can cause vessel damage and the need for additional intervention.
- Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline). Never use air or any gaseous medium to inflate the balloon.
- 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 resistance before proceeding.
- If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.
- Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter. Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.
- Always verify integrity of the catheter after removal.
- Maintain a snug seal with the hemostasis valve over the balloon catheter during advancement to prevent introduction of air into the sheath or guiding catheter. Without a snug seal, a tight fit between the balloon section of the balloon catheter and the sheath or guiding catheter may cause a risk for introduction of air and air entrainment during advancement of the balloon catheter through the sheath or guiding catheter.
- The minimal acceptable sheath introducer/guiding catheter size is printed on the package label. Do not attempt to pass the PTA catheter through smaller size sheath introducer/guiding catheter than indicated on the label. Use of a smaller than indicated accessory device can lead to introduction of air into that device as the balloon catheter is advanced, which may not be removed during air aspiration.
- Do not use with power injectors.
- The catheter system should be used only by physicians trained in the performance of arteriography and who have received appropriate training in percutaneous transluminal angioplasty.
- Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution. Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice. Failure to do so could result in air entering the vascular system.
- Caution should be taken when treating patients with poor renal function who, in the physician’s opinion, may be at risk for a contrast
- medium reaction.
- During the procedure remove blood or any other residues from the devices, using heparinized-saline soaked gauze.
- The catheter system is not intended for precise arterial blood pressure monitoring.
Potential complications include but are not limited to:
- Abrupt vessel closure
- Additional intervention
- Acute myocardial infarction
- Allergic reaction (device, contrast medium and medications)
- Arteriovenous fistula
- Hematoma at puncture site
- Hypotension / hypertension
- Inflammation/ infection/ sepsis
- Neurological events , including peripheral nerve injury, transient ischemic attack and/ or stroke
- Organ failure (single, multiple)
- Potential for balloon burst and potential complications (rated burst pressure)
- Potential for separation and potential complications (integrity to be checked before and after use)
- Procedural complications: bleeding, hypotension, access site complications
- Renal failure
- Restenosis of the dilated vessel
- Vascular complications (e.g. intimal tear, dissection, pseudoaneurysm, perforation, rupture, spasm, occlusion)
Please refer to the Instructions For Use for complete information.