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

Model Number	H74939401062500
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of hypertension.Presented to emergency department with chest pain and taken to cath lab.While preparing equipment for procedure, the wire to cutting balloon snapped off and broke.No harm to the patient.The wolverine cutting balloon delivery system broke in half as it was being loaded onto the wire.

• 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
• MDR Report Key: 10430516
• Report Number: 10430516
• Device Sequence Number: 11360903
• Product Code: NWX
• UDI-Device Identifier: 08714729888154
• UDI-Public: (01)08714729888154(17)220126(10)25107083
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/12/2020
• Report Date (Section F): 08/12/2020

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
• Operator of Device: No Information
• Device Model Number: H74939401062500
• Device Catalogue Number: H74939401062500
• Device Lot Number: 25107083
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/12/2020