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	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed, 15mm complex, concentric and irregular target lesion was located in the severely calcified first diagonal.There was timi 3 flow.A 10mmx2.25mm wolverine coronary cutting balloon was introduced.During the procedure, while the balloon markers were still at the proximal end of the lesion, the balloon could not be pushed and it was noted that the balloon was broken in half while inside the guide catheter.The proximal part of the balloon system was removed.The lesion was recrossed with another non-boston scientific wire and another 2.0x15 balloon was passed beyond the wolverine balloon.The balloon was inflated at the low pressure and then used to drag wolverine balloon back into the guide.The whole system including the guide was completely removed.There was complete retrieval of the broken wolverine balloon system.The procedure could not be completed due to inability to crack the lesion despite trying with multiple compliant and non-compliant balloons.The lesion could not be crossed with a cutting balloon.No patient complications were reported.

• 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: 12182746
• Report Number: 2134265-2021-09160
• Device Sequence Number: 936561
• Product Code: NWX
• UDI-Device Identifier: 08714729888239
• UDI-Public: 08714729888239
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: 12/11/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024923106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1