MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON 4.00X15; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number H74939401154000

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2021

Event Type  malfunction  

Event Description

Boston scientific cutting balloon was in the process of being inserted into the sheath when the shaft of the balloon snapped.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON 4.00X15
• 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: 11313151
• MDR Text Key: 231352994
• Report Number: 11313151
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2021

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: H74939401154000
• Device Catalogue Number: H74939401154000
• Device Lot Number: 26417127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 78