Instructions for Use (Brief Summary) - Fox sv Small Vessel PTA Catheter (U.S.)

Rx ONLY

INDICATIONS
The FOX sv PTA Catheter is intended for dilatation of lesions in the femoral,renal, iliac, popliteal, peroneal, and profunda arteries. This catheter is not intended for the expansion or delivery of stents.

CONTRAINDICATIONS
Inability to cross lesion with a guide wire.

The FOX sv PTA Catheter is contraindicated for use in the coronary arteries.

WARNINGS

• This device should only be used by physicians who are experienced and have a thorough understanding of the clinical and technical aspects of PTA.
• Single use only – do not resterilize! Catheters and accessories should be discarded after one procedure. They are extremely difficult to clean adequately after being exposed to biological materials and may cause adverse patient reactions if reused. Cleaning these products may alter their structural properties. Accordingly, Abbott Vascular Devices will not be responsible for any direct, incidental or consequential damages resulting from reuse of the catheter.

PRECAUTIONS

• Do not use if inner package is damaged or opened.
• Use prior to the expiry date.
• Carefully inspect the catheter prior to use to verify that the 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.
• Precautions to prevent or reduce clotting should be taken when any catheter is used.
• Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution via the guide-wire access port prior to use. Consider the use of systemic heparinization.
• When the system is introduced into the vascular system, it should be manipulated only under high quality fluoroscopy.
• The FOX sv PTA Catheter must always be introduced, moved and or withdrawn over a guide wire (max 0.018”).
• Never attempt to move the guide wire when the balloon is inflated.
• Do not advance the FOX sv PTA Catheter against significant resistance. The cause of resistance should be determined via fluoroscopy and remedial action taken.
• The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the FOX sv PTA Catheter through a smaller size sheath introducer than indicated on the label.
• The size of the inflated balloon should be selected not to exceed the diameter of the artery immediately distal or proximal to the stenosis.
• Inflation in excess of the rated burst pressure may cause the balloon to rupture.
• Not intended for pressure monitoring or injection of contrast media or other fluids.

POTENTIAL COMPLICATIONS
The following complications may occur as a result of PTA, but may not be limited to:

• Spasm reactions of vessel
• Artery wall injuries of different degrees, including perforation and dissection
• Hemorrhage or hematoma
• Arteriovenous fistula, false aneurysm
• Vascular thrombosis, systemic embolization
• Infection
• Pyrogenic reaction
• Amputation
• Death

Complications related to concomitant medication, e.g.:

• Drug reactions
• Bleeding from anticoagulation/antiplatelet medication
• Allergic reactions to contrast medium

SELECTION AND PREPARATION OF DEVICE AND COMPATIBILITY WITH ACCESSORIES
Selection of balloon size and compatibility of system to accessories

The expanded diameter of the balloon should not exceed that of the artery just proximal to the stenosis.

Verify that the selected accessories accommodate the balloon catheter as labeled.

It is advantageous to use the balloon catheter with an introducer. Refer to package label for recommended introducer sheath size.

Preparation of PTA-balloon

It is very important to check before use that the packaging has not been damaged in a way that might have rendered the catheter unsterile. It is also important at the same time to verify that the chosen catheter is the correct one for planned procedure.

To verify the integrity of the PTA catheter, inflate the balloon and make sure that all the air is eliminated and there is no leakage through any of the different connections. The following steps may be taken:

1) Fill a syringe with equal volumes of contrast medium and normal saline.

2) Attach the syringe to the connector of the balloon lumen. Hold the catheter with the distal tip pointing down.

3) Remove protective tubing of the balloon.

4) Inject enough contrast medium to partially inflate the balloon.

5) Deflate the balloon by drawing back on the syringe plunger, thereby drawing the air bubbles from the balloon into the syringe.

6) Repeat steps 4 and 5 until all of the air within the balloon has been displaced by contrast medium.

7) Aspirate firmly to remove all inflation media and refold the balloon.

8) Slide the protection tubing back over the balloon to achieve the smallest profile prior to introduction into vascular system.

INTRODUCTION AND DILATATION
Introduction of the system

1) The PTA catheter is designed to be introduced percutaneously using the Seldinger technique.

2) At the time the catheter is ready for introduction into the vascular system, the balloon protection tubing should be removed completely from the catheter.

3) Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site. It is advantageous to use the balloon catheter with an introducer to facilitate entry.

Note: Perform all further catheter manipulations under fluoroscopy.

4) Position the catheter with the center of the balloon in the middle of the stenosis. The radiopaque marker bands indicate the stated length of the balloon.

Dilatation of the balloon

5) When an acceptable position has been obtained, inflate the balloon to achieve the desired dilatation.

Caution: Do not exceed the rated burst pressure. Higher pressures may damage the balloon or catheter.

6) Deflate the balloon by aspirating the inflation syringe or inflation device.

7) Maintaining a vacuum on the balloon, withdraw the catheter. If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as one unit.

8) The results should be checked by angiography.

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