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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the blade detached from the cutting balloon.A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.The wolverine was advanced and inflated twice at 12 atmospheres.On the third inflation the lesion was not yielding.The wolverine was inflated to a higher pressure (16 atm) for a couple more inflations.The wolverine was removed.The lesion was then successfully dilated with a 3.5 x 12 emerge balloon catheter.A stent was then attempted to cross the lesion multiple times but was unsuccessful.The stent was removed and a guide extension catheter was advanced along with the balloon catheter.The stent was advanced and successfully implanted.Post procedure it was observed that the center piece of the blade was missing on the wolverine cutting balloon.The distal and proximal part of the blade remained attached to the balloon.The physician stated that the detached blade became fixated into the wall and was now covered and trapped behind a stent.There were no complications 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: 12704394
• Report Number: 2134265-2021-13510
• Device Sequence Number: 4498893
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0027852409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other