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

Model Number	H74939401102750
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of coronary artery disease.Procedure is elective staged percutaneous coronary intervention of diagonal artery.As the wolverine (2.75 x 10 balloon) entered the guide, shaft broke inside catheter upon advancement.All parts were successfully removed without known harm to patient.

• 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: 11146806
• Report Number: 11146806
• Device Sequence Number: 13664635
• Product Code: NWX
• UDI-Device Identifier: 08714729888253
• UDI-Public: (01)08714729888253(17)220807(01)25828750
• 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): 01/07/2021
• Report Date (Section F): 01/07/2021

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: Health Professional
• Device Model Number: H74939401102750
• Device Catalogue Number: H74939401102750
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2021
• Patient Sequence Number: 1
• Patient Weight: 112
• Date Report Sent to FDA: 01/07/2021