Instructions for Use (Brief Summary) - Fox Plus PTA Catheter

Rx ONLY

INDICATIONS
The Fox Plus PTA Catheter is intended for dilation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.

CONTRAINDICATIONS
Inability to cross lesion with a guide wire.

The Fox Plus 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 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• The Fox Plus PTA Catheter must always be introduced, moved and or withdrawn over a guide wire (0.035").
  
• Never attempt to move the guide wire when the balloon is inflated.
  
• Do not advance the Fox Plus PTA Catheter against significant resistence. The cause of resistence 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 Plus 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
  
• Venous rupture
  
• Hemorrhage or hematoma
  
• Arteriovenous fistula
  
• Pseudo aneurysm
  
• Vascular thrombosis, systemic embolization
  
• Device Embolization
  
• Additional interventional or surgical procedure
  
• Infection
  
• Pyrogenic reaction
  
• Amputation
  
• Death
  

Complications related to concomitant medication, e.g.:

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

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