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); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon became stuck in the lesion and the shaft split in half.A percutaneous coronary intervention was being performed.The target lesion was located in a very diseased and calcified in-stent restenosis of the proximal ramus/left main artery.During procedure, a 10mmx2.50mm wolverine coronary cutting balloon was advanced several times.It was noted that the wolverine cutting balloon may have been undersized due to the extreme disease.When trying to remove the wolverine cutting balloon, it was noted that the device was stuck in the lesion and they had to pull to get it out.When they pulled the balloon the shaft split in half.Multiple attempts were made to remove the balloon.Finally they used an nc emerge balloon to trap the distal shaft of the wolverine cutting balloon into the guide and they were able to pull everything out.No further patient complications were reported and patient was fine.
Event or Problem Description
It was reported that the balloon became stuck in the lesion and the shaft split in half.A percutaneous coronary intervention was being performed.The target lesion was located in a very diseased and calcified in-stent restenosis of the proximal ramus/left main artery.During procedure, a 10mmx2.50mm wolverine coronary cutting balloon was advanced several times.It was noted that the wolverine cutting balloon may have been undersized due to the extreme disease.When trying to remove the wolverine cutting balloon, it was noted that the device was stuck in the lesion and they had to pull to get it out.When they pulled the balloon the shaft split in half.Multiple attempts were made to remove the balloon.Finally they used an nc emerge balloon to trap the distal shaft of the wolverine cutting balloon into the guide and they were able to pull everything out.No further patient complications were reported and patient was fine.It was further reported that the 90% stenosed target lesion was located in the non tortuous obtuse marginal artery.The device was removed with trapping the rest of the balloon that broke off the shaft was removed.Distal balloon was intact.The shaft broke when trying to retract it from body, which warranted trapping it.

• 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: 10976596
• Report Number: 2134265-2020-16896
• Device Sequence Number: 3034038
• Product Code: NWX
• UDI-Device Identifier: 08714729888246
• UDI-Public: 08714729888246
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: 06/25/2022
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0025643657
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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: Required Intervention