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

Model Number H74939401102750

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2021

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 226047706
• Report Number: 11146806
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888253
• UDI-Public: (01)08714729888253(17)220807(01)25828750
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: H74939401102750
• Device Catalogue Number: H74939401102750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 112