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

Model Number	H74939401154000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While undergoing coronary intervention a wolverine coronary cutting balloon broke apart while it was being introduced in the guide catheter.Both pieces of the cutting balloon was retrieved and a new cutting balloon and guide catheter was used.Patient tolerated procedure well.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; saint paul MN 55112
• MDR Report Key: 22748020
• Report Number: 22748020
• Device Sequence Number: 8651665
• Product Code: NWX
• UDI-Device Identifier: 08714729888390
• UDI-Public: (01)08714729888390
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/31/2025
• Report Date (Section F): 07/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: H74939401154000
• Device Catalogue Number: H74939401154000
• Device Lot Number: 33672968
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Date Report Sent to FDA: 07/31/2025