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

Model Number	3854
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch (b)(4) that balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.Upon insertion of the balloon into the guide catheter, blood was noted to be leaking into the hub of the balloon through the y-connector.Inspection of the balloon upon removal revealed a leak in the distal shaft.Additional it was noted that the balloon burst.The ballon was withdrawn immediately, and the patient was not adversely affected.The procedure was completed using another device.No patient complications were reported as a result of this event.
Event or Problem Description
It was reported via medwatch 3902560000-2024-8062 that balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.Upon insertion of the balloon into the guide catheter, blood was noted to be leaking into the hub of the balloon through the y-connector.Inspection of the balloon upon removal revealed a leak in the distal shaft.Additional it was noted that the balloon burst.The balloon was withdrawn immediately, and the patient was not adversely affected.The procedure was completed using another device.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
: h10 related report number: included related medwatch report number.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20055564
• Report Number: 2124215-2024-51841
• Device Sequence Number: 8118194
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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 Expiration Date: 06/07/2025
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0031775436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/04/2024
• Date Device Manufactured: 06/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male