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

Model Number	3855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: estimated based on original aware date since the event date was not provided.A wolverine cb mr, us 15mmx3.00mm was returned for analysis.A visual examination of the blades and pads identified that the balloon wings were found to be wrapped.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.A visual and tactile examination was completed on the shaft of the device.A hypotube break was identified at 120cm proximal from the tip of the device.The proximal section of the device including the manifold was not returned for analysis.A hypotube kink was also noted at 98 cm proximal from the tip.A visual and tactile examination was completed, and no issues were noted.
Event or Problem Description
Reportable based on device analysis completed on 29apr2021.It was reported that the shaft broke in a location which would not enter the patient.The target lesion was calcified.A 15mm x 3.00mm wolverine cb mr cutting balloon was introduced but the shaft broke about 8cm from the hub while trying to cross the lesion.The device was removed and the procedure completed with another of the same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed the shaft break occurred in a location which could enter the patient.

• 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: 11807951
• Report Number: 2134265-2021-06137
• Device Sequence Number: 3634881
• Product Code: NWX
• UDI-Device Identifier: 08714729888352
• UDI-Public: 08714729888352
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 02/04/2023
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0026754529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1