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	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021.
Event or Problem Description
It was reported that a shaft break occurred.A 6mmx3.00mm wolverine coronary cutting balloon was selected for use.During insertion, it was noted that the shaft broke outside the patient's body.There was no patient interaction and the procedure was completed with another of same device.No patient complications were reported and patient was doing well post procedure.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to (b)(6) 2021.Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination of the hypotube shaft identified no kinks.The device was received in two sections as a result of a break in the distal extrusion.The break was located at 4mm distal from the port site in the inner and outer extrusions.An examination of the distal extrusion identified stretching and bunching along its length.As a result of this bunching the proximal end of the balloon was inverted and the proximal and distal markerbands were pulled towards each other.Further analysis identified a kink in the midshaft at 8mm proximal from the port site.A visual examination identified that the balloon was in a deflated state.As a result of the bunching and stretching along the inner, the proximal end of the balloon was inverted.No tears or holes were visible in the balloon material.All blades were securely bonded and no damage to the blades were noted.There was slight tip damage at its distal edge.A visual and microscopic examination found no issue with the actual marker bands however, due to the severe stretching and bunching of the inner extrusion the markerband were pulled towards each other.No other damage was present.
Event or Problem Description
It was reported that a shaft break occurred.A 6mmx3.00mm wolverine coronary cutting balloon was selected for use.During insertion, it was noted that the shaft broke outside the patient's body.There was no patient interaction and the procedure was completed with another of same device.No patient complications were reported and patient was doing well post procedure.

• 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: 11334716
• Report Number: 2134265-2021-01499
• Device Sequence Number: 16349665
• Product Code: NWX
• UDI-Device Identifier: 08714729888178
• UDI-Public: 08714729888178
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 07/22/2021

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: 10/20/2022
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0026217022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1