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	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.The target lesion was located in the mildly tortuous and moderately calcified artery.A 10mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, the balloon was loaded onto a run through and the doctor went to advance through the copilot when the mid shaft got separated.The device was removed from the patient's body successfully and the procedure was completed with a different device.No complications were reported.
Event or Problem Description
It was reported that the device was fractured.The target lesion was located in the mildly tortuous and moderately calcified artery.A 10mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, the balloon was loaded onto a run through and the doctor went to advance through the copilot when the mid shaft got separated.The device was removed from the patient's body successfully and the procedure was completed with a different device.No complications were reported.It was further reported that the device was outside of the body at the time of the event and it never entered the body of the patient as this was noted during preparation.Also, the break was roughly 30-40% up the shaft from the balloon.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18395174
• Report Number: 2124215-2023-73778
• Device Sequence Number: 14186140
• Product Code: NWX
• UDI-Device Identifier: 08714729888246
• UDI-Public: 08714729888246
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: Other
• Device Expiration Date: 03/01/2025
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0031156920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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
• Patient Sex: Unknown