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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon broke.A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.Prior the procedure, it was noted that the balloon broke in half when taken out of the box.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
The wolverine cb mr, us 10mmx3.00mm balloon delivery system device was returned for analysis.A visual examination identified that the balloon folds were tightly wrapped.A visual and tactile examination found that a break was confirmed in the hypotube.The break was located at 76.8cm distal from the strain relief.The distal section of the break including the extrusion, balloon and tip were not returned.The section of the hyptube received was kinked in multiple locations.The damage to the hypotube is consistent with excessive force having been applied to the hypotube shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the balloon broke.A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.Prior the procedure, it was noted that the balloon broke in half when taken out of the box.The procedure was completed with another of the same device.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: 11317144
• Report Number: 2134265-2021-01549
• Device Sequence Number: 790610
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 11/25/2022
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0026423323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1