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

Model Number	3853
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 as no event date was reported.
Event or Problem Description
It was reported that a shaft break occurred.A 6mmx4.00mm wolverine coronary cutting balloon was selected for use.During the course of the procedure, it was noted that the device came off the shaft when they were pulling it back into the guide.The device was not intact.No patient complications were reported.
Event or Problem Description
It was reported that a shaft break occurred.A 6mmx4.00mm wolverine coronary cutting balloon was selected for use.During the course of the procedure, it was noted that the device came off the shaft when they were pulling it back into the guide.The device was not intact.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.Device evaluated by mfr: the device was returned for evaluation.The device was returned with a complete shaft break present at 51.9 cm distal from the strain relief.The hub portion of the device (51.9 cm in length) was free from the guide catheter.The remaining portion of the device including the balloon was within the guide catheter and could not be removed due to the presence of an s shaped kink present in the hypotube.The guide catheter was damaged and partially detached at this point, but this detachment was not a complete separation.The wire component of the guide catheter material kept the guide catheter from separating.A snip was used to cut the wire component.Once the guide catheter was separated, there was no issue with removing the remaining portion of the device from the guide catheter.This portion measured approximately 90.6cm in length and included the complete balloon.An s bend shaped kink was present at approximately 6.5cm distal to the break point.A visual examination identified that the balloon wings were found to be in a deflated state and had been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.

• 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: 11400282
• Report Number: 2134265-2021-01931
• Device Sequence Number: 19678642
• Product Code: NWX
• UDI-Device Identifier: 08714729888215
• UDI-Public: 08714729888215
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: 08/06/2021
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0024225629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1