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 Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred and dye leaked.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the shaft broke proximal to the balloon.The dye leaked but the device was still intact.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was in a deflated state.There were no issues noted with the balloon material.No tears or holes were visible in 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 identified multiple kinking along the length of the hypotube.A visual and tactile examination identified a kink in the midshaft extrusion.The kink was located at 2cm proximal to the port.As part of a leakage test the device was attached to an encore inflation unit and during an attempt to inflate the balloon, a pinhole leak was identified in the outer distal extrusion.The leak was located at 1cm distal to the port.Using a blade the outer was removed and an examination of the inner extrusion found a pinhole in the same location (1cm distal from the port).The exact cause of the pinholes in the inner and outer extrusions is unknown.One possibility is that the guidewire punctured out through the inner and outer.However, no issues were identified with the extrusion which could potentially have contributed to a wire puncturing through the lumens.No other damage was present.
Event or Problem Description
It was reported that a shaft break occurred and dye leaked.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the shaft broke proximal to the balloon.The dye leaked but the device was still intact.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: 11419019
• Report Number: 2134265-2021-02119
• Device Sequence Number: 2775613
• Product Code: NWX
• UDI-Device Identifier: 08714729888390
• UDI-Public: 08714729888390
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/22/2021

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: 11/28/2022
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0026432930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1