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

Model Number	H74939401153000
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon rupture and shaft break occurred, requiring additional device to resolve.The 100% stenosed target lesion was located in the severely calcified and mildly tortuous mid to proximal left anterior descending artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated three times at 20 atmospheres in the mid left anterior descending artery.The balloon was pulled back to the proximal left anterior descending artery and ruptured at 20 atmospheres for 20 seconds.It was pulled back into the left main and got stuck on the left main stent but still could not be pulled back.When the shaft was attempted to be removed, it broke at 12 cm from the distal tip.A balloon was used to trap the detached shaft in the guide catheter and was able to remove it all together.The device was completely removed from the patient and the procedure was completed using an alternate method.No patient complications were reported.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: 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: 21139673
• Report Number: 2124215-2024-83686
• Device Sequence Number: 12469908
• Product Code: NWX
• UDI-Device Identifier: 08714729888352
• UDI-Public: 08714729888352
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2026
• Device Model Number: H74939401153000
• Device Catalogue Number: H74939401153000
• Device Lot Number: 0034678733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/13/2025
• Date Device Manufactured: 08/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 190 CM VERSATURN ABBOTT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown