INDICATIONS
The Advocate 014 PTA catheter is intended for balloon dilation of the Iliac, Femoral, Popliteal, Infrapopliteal, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
CONTRAINDICATIONS
The Advocate™ PTA Catheter is contraindicated for use in coronary arteries or the neurovascular, or when unable to cross the target lesion with a guidewire or for the expansion or delivery of stents
WARNINGS
• This device is supplied STERILE and is intended for single patient use. Reuse, reprocessing or resterilisation may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilisation may also create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
• This device should only be used by physicians who are experienced and knowledgeable of the clinical and technical aspects of percutaneous transluminal angioplasty.
• To reduce the potential for vessel damage, the inflation diameter of the balloon should approximate the diameter of the vessel lumen at the intended inflation site.
• CAUTION: do not exceed the rated burst pressure. A pressure gauge is recommended to monitor pressure. Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.
• Never use air or any gaseous medium to inflate the balloon.
• When the catheter is exposed to the vascular system, it should be manipulated under highquality fluoroscopic observation.
• Do not manipulate the balloon in an inflated state.
• Use the catheter prior to the expiration date specified on the package.
• The catheter is not recommended for pressure measurement or fluid injection.
PRECAUTIONS FOR USE
• To avoid kinking, advance the catheter slowly, in small increments until the proximal end of the guidewire emerges from the catheter.
• Dilation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.
• The device should be used with caution for procedures involving calcified lesions due to the abrasive nature of these lesions.
.• Care should be taken not to over tighten haemostatic valve around the catheter shaft as constriction may occur affecting inflation/deflation of the balloon.
• If resistance is encountered at any time during the insertion procedure, do not force passage. Resistance may cause damage to device or lumen. Carefully withdraw the catheter.
• If resistance is felt upon removal, then the balloon, guidewire and the introducer sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly grasping the balloon catheter and introducer sheath as a unit and withdrawing both together, using a gently twisting motion combined with traction.
• Before removing the catheter from the introducer sheath it is very important that the balloon is completely deflated.
• After use, eliminate the product according to safety requirements related to products contaminated by blood
