MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 39345-351510

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 3.5mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at 6atm within 10 seconds.The device was remove using normal method without any problem.The procedure was completed with a different device.No complications were reported, and patient was good post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to attempt to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at 8mm distal to the proximal marker band.The markerbands and blades and tip section of the device were visually examined, and no issues were noted with the markerbands, blades or tip of the device.All blades were present and fully bonded to the balloon material.A visual and tactile examination of the hypotube shaft found no issues with the shaft.

Event Description

It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 3.5mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at 6atm within 10 seconds.The device was remove using normal method without any problem.The procedure was completed with a different device.No complications were reported, and patient was good post procedure.

• Brand Name: WOLVERINE PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19068260
• MDR Text Key: 339882869
• Report Number: 2124215-2024-20936
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39345-351510
• Device Catalogue Number: 39345-351510
• Device Lot Number: 0029698271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1