WOLVERINE™ Cutting Balloon Micro-Surgical Dilatation Catheter

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

eIFU 51361541

INTENDED USE / INDICATIONS FOR USE

The Wolverine Cutting Balloon Device is indicated for dilation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics:

• Discrete (< 15 mm in length), or tubular (10 mm to 20 mm in length)
• Reference vessel diameter (RVD) of 2.00 mm to 4.00 mm
• Readily accessible to the device
• Light to moderate tortuosity of proximal vessel segment
• Nonangulated lesion segment (< 45°)
• Smooth angiographic contour
• Absence of angiographically visible thrombus

CONTRAINDICATIONS

The Wolverine Cutting Balloon Device is contraindicated for use in:

• Delivery through the side cell of a previously placed stent as the deflated Cutting Balloon could become entangled in the stent.
• Coronary artery spasm in the absence of a significant stenosis.

WARNINGS

• Exercise extreme care when treating a lesion distal to a stent. When treating lesions at a bifurcation, the device can be used prior to placing a stent, but should not be taken through the side cell of a stent to treat the side branch of a lesion at a bifurcation. 
• The atherotomy process, because of its mechanism of action, may pose a greater risk of perforation than that observed with conventional PTCA. To reduce the potential for vessel damage, the inflated diameter of the device should approximate a 1:1 ratio of the diameter of the vessel just proximal and distal to the stenosis. 
• The atherotomy process in patients who are not acceptable candidates for coronary artery bypass surgery requires careful consideration, including possible hemodynamic support during the atherotomy process, as treatment of this patient population carries special risk. 
• Balloon pressure should not exceed the rated burst pressure.
• When performing percutaneous atherotomy, the availability of on-site surgical backup should be included as a clinical consideration. 

PRECAUTIONS

• The device should be used only by physicians experienced in the performance of PTCA.
• If difficulty is experienced during balloon inflation, do not continue; remove the device and do not attempt to use it.
• Excessive handling can cause catheter damage such as delivery system kinking, shaft rupture or separation, which maynecessitate additional procedures. Do not bend or kink the device during removal from packaging.
• Infusion of any medium through the guidewire lumen other than heparinized saline may compromise device performance. 
• Do not attempt to reposition a partially inflated balloon.
• Do not use a guidewire having a diameter greater than 0.014 in (0.36 mm). 
• Used devices may pose a biohazard risk and must be handled and disposed of properly.

Potential ADVERSE EVENTS

Potential adverse events include, but are not limited to, the following:

• Abrupt closure, slow flow/no reflow
• Additional intervention including surgery
• Arrhythmia, including ventricular fibrillation or heart block
• Bleeding, hemorrhage or hematoma
• Cardiac tamponade/pericardial effusion
• Cerebrovascular accident (stroke or transient ischemic attack)
• Death
  
• Drug reactions, including allergy
• Embolism (air, tissue, device fragments, plaque)
• Hemodynamic compromise including vasovagal reaction
• Infection
• Myocardial ischemia or infarction
• Radiation injury
• Renal failure/ insufficiency
• Respiratory failure/ insufficiency
• Thrombosis
• Vasospasm
• Vessel occlusion
• Vessel injury (perforation, dissection, rupture, aneurysm, pseudoaneurysm, arteriovenous fistula) possibly requiring surgical intervention