WOLVERINE Coronary Cutting Balloon

• 2 recalls, same reason

  • Terminated Z-2137-2013 FDA Class II ·initiated 31 Jul 2013 ·on shared PMA P950020
  • Terminated Z-2138-2013 FDA Class II ·initiated 31 Jul 2013 ·on shared PMA P950020

  Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic

• • Terminated Z-0621-2009 FDA Unclassified (pre-2012) ·initiated 21 Nov 2008 ·on shared PMA P950020

  For one batch/lot of flextome Cutting Balloon (OTW), an incorrect compliance chart was packaged inside the sterile pouch. For the affected batch/lot, the compliance chart packed inside the pouch of the 4.0mm diameter Flextome Cutting Balloon device is for a 3.5mm diameter Flextome Cutting Balloon device. This labeling discrepancy could create a procedural delay as users seek to explain the discr

• • Terminated Z-1512-06 FDA Unclassified (pre-2012) ·initiated 21 Jul 2006 ·on shared PMA P950020

  Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)

• 2 recalls, same reason

  • Terminated Z-0409-06 FDA Unclassified (pre-2012) ·initiated 7 Dec 2005 ·on shared PMA P950020
  • Terminated Z-0410-06 FDA Unclassified (pre-2012) ·initiated 7 Dec 2005 ·on shared PMA P950020

  The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade name

Flexatome Cutting Balloon

Generic name

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

FDA applicant

Boston Scientific Corp

PMA number

P950020 ↗

FDA product code

NWX

Device class

Class III

Advisory committee

Cardiovascular

FDA decision

APPR Approved

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• What types of coronary artery blockages is the Wolverine Cutting Balloon specifically designed to treat, and what are the key vessel size requirements?

  The Wolverine Cutting Balloon is designed for **high-pressure balloon-resistant lesions** in coronary arteries with specific characteristics, such as discrete lesions (up to 15 mm long) or tubular lesions (10–20 mm long). It is intended for vessels with a **reference diameter between 2.0 mm and 4.0 mm**, ensuring compatibility with the device’s cutting mechanism to enhance lumen expansion in select obstructions.

• Is the Wolverine Cutting Balloon intended for reuse, or is it single-use with additional preparation required?

  The Wolverine Cutting Balloon is supplied as a **single-use, non-sterile** device. It requires **terminal sterilization** before use, meaning it must be sterilized by the healthcare facility under aseptic conditions prior to deployment in the coronary angiography suite.

• What storage conditions are necessary to maintain the integrity and performance of the Wolverine Cutting Balloon?

  The Wolverine Cutting Balloon must be stored under **proper conditions** to preserve its performance. While exact storage details are not specified, compliance with **MRI safety standards** is explicitly mentioned as essential, indicating it should be stored away from magnetic fields. Additionally, it should be kept in a clean, dry environment to prevent contamination or damage.

• What are the key anatomical and lesion characteristics that determine whether this device is suitable for a given patient?

  The Wolverine Cutting Balloon is intended for **discrete or tubular lesions** (≤15 mm or 10–20 mm long) in coronary arteries with a **reference vessel diameter of 2.0 mm to 4.0 mm**. It is best suited for **light to moderate tortuosity** in the proximal vessel segment, **non-angulated lesion segments (<45 degrees)**, smooth angiographic contours, and lesions without **visible thrombus or calcification**. These criteria ensure optimal performance of the cutting mechanism.