Viatrac™ 14 Plus Balloon Dilatation Catheter

INDICATIONS

The Viatrac™ 14 Plus Peripheral Dilatation Catheter is indicated:

• To dilate stenosis in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries).
• For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

CONTRAINDICATIONS

• Inability to cross lesion with a guide wire
• Use in the coronary arteries

WARNINGS

For single use only. DO NOT resterilize and / or reuse it, as this can compromise device performance and increase the risk of cross-contamination due to inappropriate reprocessing.

Use the catheter prior to the “Use-by date” specified on the package.

Any use for procedures other than those indicated in these instructions is not recommended.

To reduce the potential for vessel injury, the inflated diameter of the balloon should approximate the diameter of the normal or undiseased vessel segment, just proximal and distal to the stenosis.

Do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead, prepare a new catheter.

If a distal protection device is used, follow the manufacturer’s instruction for use. Allow and maintain adequate distance between the PTA catheter and the distal protection device to avoid engagement.

In cases of extreme vessel tortuosity, it may be necessary to reposition the catheter in a straight segment of the vessel in order to allow guide wire exchange. Do not continue to use a catheter if excessive resistance is felt during guide wire exchanges. Instead, prepare a new catheter.

Persons with known history of allergies to any of the components of this device listed below may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials contained in the device, and a thorough history of allergies must be discussed. This device contains silicone coating, polyamide, polyethylene, and polyether block amide that come into direct contact with the patient’s tissues or blood during use.

If an unexpected loss of pressure occurs, the user should place the inflation device into a neutral (i.e., zero) pressure state and, using fluoroscopy, slowly remove the balloon catheter from the patient. If at any time during the withdrawal process there is resistance noted, the cause of resistance should be determined. If the resistance involves the guiding catheter / introducer sheath, both the guiding catheter / introducer sheath and the balloon catheter are to be removed as a single unit. Once the balloon catheter has been completely removed from the patient, determine the root cause of the loss of pressure (e.g., inflation device, balloon catheter, connections, etc.) and replace the component. Do not reuse the balloon catheter if it is determined to be the root cause of the loss.

PRECAUTIONS

Use only the recommended balloon inflation medium. 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 via fluoroscopy before proceeding.

Treatment of moderately or heavily calcified lesions increases the risk of acute closure, vessel trauma, balloon burst, balloon entrapment, and associated complications. If resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.

In the event of catheter damage / separation, recovery of the foreign body should be performed based on physician determination of individual patient condition and appropriate retrieval protocol.

This medical device should only be used by physicians who are experienced and have a thorough understanding of the clinical and technical aspects of PTA.

Do not torque the catheter more than one (1) full turn.

Inspect all product prior to use. Do not use if the package is open or damaged.

Prior to angioplasty, the PTA catheter should be examined to verify functionality and ensure that its size is suitable for the specific procedure for which it is to be used.

Flush or rinse all products entering the vascular system with sterile heparinized normal saline or a similar solution via the guide wire access port prior to use. Consider the use of systemic heparinization.

Never attempt to move the guide wire when the balloon is inflated.

The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the Viatrac™ 14 Plus Peripheral Dilatation Catheter through a smaller sized sheath introducer than indicated on the label.

Do not reinsert the PTA catheter into the coil dispenser after procedural use.

Bench testing was conducted with 0.014” (0.36 mm) constant diameter guide wires to establish guide wire compatibility. If another type of guide wire is selected with a different dimensional profile, the compatibility (e.g., wire resistance) should be considered prior to use.

The safety and effectiveness of this PTA balloon catheter for the treatment of in-stent restenosis (ISR) have not been established.

This medical device is not recommended for use in lesions that may require inflation higher than those recommended for this catheter.

Balloon pressure should not exceed the RBP. The RBP is based on results of in vitro testing. Higher pressure can damage the balloon or catheter or over-distend the selected artery.

Inflation in excess of the RBP may cause the balloon to rupture. Use of a pressure monitoring device is recommended.

Employ aseptic techniques during removal from the package and during use.

Carefully inspect the catheter prior to use to verify that it 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.

This PTA catheter must always be introduced, moved, and / or withdrawn over a 0.014” (0.36 mm) guide wire.

If resistance is felt during removal of either the balloon catheter from the guide wire or the guide wire from the balloon catheter, the balloon catheter and guide wire should be removed together as a unit and set aside. Neither the balloon catheter nor the guide wire should be reused for additional attempts to dilate the artery, either separately or in combination.

Precautions to prevent or reduce clotting should be taken when any catheter is used prior to, during, and after the procedure.

Shaft diameter differences should be taken into consideration when opening and tightening the hemostatic valve and upon withdrawal of the catheter.

It is important that the hemostatic valve be closed tightly enough to prevent blood leakage around the catheter shaft, yet not so tight that it restricts the flow of contrast into and out of the balloon or restricts guide wire movement.

Inadequate removal of the protective sheath or stylet prior to use may cause medical device damage.

ADVERSE EVENTS

Potential adverse events include but are not limited to:

• Allergic reaction, hypersensitivity or toxic reaction to contrast agent, anesthesia, medical device material (silicone coating, polyamide, polyethylene, polyether block amide), and drug reactions to anticoagulation or antiplatelet drugs
• Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture
• Bleeding (ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage) Cardiac arrhythmias (including conduction disorders, atrial, and ventricular arrhythmias)
• Cardiac failure
• Cardiac ischemic conditions (including myocardial ischemia, myocardial infarction, and unstable or stable angina pectoris)
• Death
• Detachment of a system component or implantation in an unintended site
• Embolism (air, tissue, plaque, thrombotic material, device)
• Fever
• Heparin induced thrombocytopenia and other coagulopathy
• Hyperperfusion syndrome
• Hypotension
• Hypertension
• Ischemia or infarction not covered under other Adverse Events
• Limb ischemia, acute
• Loss / necrosis of target limb (amputation of toe, foot, and / or leg)
• Pain
• Peripheral nerve injury
• Pulmonary embolism
• Renal failure
• Sepsis / infection
• Shock
• Stenosis or restenosis
• Stroke / cerebrovascular accident (CVA) and transient ischemic attack (TIA)
• Thrombosis
• Total occlusion or abrupt closure
• Venous thromboembolism
• Vessel spasm 
• Worsening claudication or rest pain
• Worsening of the pre-existing condition