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

Model Number	3855
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure the device could not cross the lesion.The shaft broke the guide catheter.The device was removed without any problem.The procedure was completed with another of same device.No complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that a shaft break occurred.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure the device could not cross the lesion.The shaft broke the guide catheter.The device was removed without any problem.The procedure was completed with another of same device.No complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified no issues with the balloon which could have potentially contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.The device was received in two sections as a result of a break in the hypotube.The break was located at 19.5cm distal to the strain relief.Both sections of the hypotube were kinked at various locations.The damage to the hypotube is consistent with excessive force having been applied to the hypotube shaft.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11942493
• Report Number: 2134265-2021-07272
• Device Sequence Number: 4176072
• Product Code: NWX
• UDI-Device Identifier: 08714729888390
• UDI-Public: 08714729888390
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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 Expiration Date: 01/23/2023
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0026683358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1