PCP030080090

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<h2>Indications, Safety, and Warnings</h2> <h3>Reference statement</h3> Indications for use: The Pacific™ Plus PTA catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Catheters with balloon diameters of 4–7 mm (in all lengths) are also indicated for stent postdilatation in the peripheral arteries. Contraindications: The catheter is contraindicated for use in coronary arteries or the neurovasculature. It is also contraindicated when the guidewire is unable to cross the target lesion. Potential adverse events: Complications associated with the use of the Pacific™ Plus PTA catheter are similar to those associated with standard percutaneous transluminal angioplasty (PTA) procedures. Possible complications may include, but are not limited to: <ul> <li>Puncture related: Arteriovenous fistula, local hematoma, local hemorrhage, local infections, local or distal thromboembolic episodes, pseudoaneurysm, thrombosis</li> <li>Dilatation related: Acute reocclusion necessitating surgical intervention, dissection in the dilated artery wall, perforation of the artery wall, prolonged spasms, restenosis of the dilated artery, total occlusion of the peripheral artery</li> <li>Angiography related: Allergic reaction to contrast medium, arrhythmias, death, drug reactions, endocarditis, hypotension, pain and tenderness, sepsis/infection, short-term hemodynamic deterioration, systemic embolization</li> </ul> Important: Please reference the instructions for use for a complete listing of indications, contraindications, warnings and precautions, adverse effects, and suggested procedure. Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician. UC201712530-01a EN

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