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	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon shaft got broke.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, upon insertion on a 6x24 non-bsc device, it was noted that the shaft broke approximately 30cm deep.The device was removed completely.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that the balloon shaft got broke.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, upon insertion on a 6x24 non-bsc device, it was noted that the shaft broke approximately 30cm deep.The device was removed completely.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was returned in two pieces.There was a complete shaft break present at 82.9 cm distal the end of the strain relief.A visual examination identified that the balloon folds were in a wrapped state and had not been subject 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.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination of the hypotube identified multiple hypotube kinks as well as a shaft polymer extrusion kink at 4mm proximal to the guidewire port.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15184055
• Report Number: 2124215-2022-29469
• Device Sequence Number: 5847577
• Product Code: NWX
• UDI-Device Identifier: 08714729888284
• UDI-Public: 08714729888284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 05/29/2024
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0029494451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH - 6X24 ARROW SHEATH; INTRODUCER SHEATH - 6X24 ARROW SHEATH
• Patient Age: 73 YR
• Patient Sex: Male