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

Model Number	H74939401103250
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shaft break occurred and was removed by snaring.The target lesion was located in the coronary artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention.During the procedure, it was noted that the device was broken on the shaft before the balloon.The device was removed from the guide catheter in multiple pieces using a snare and the procedure was completed.No patient complications were reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to 06/01/2025 as no event date was reported.Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break at 84cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Balloon material was reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No issues were noted with the blades.Pads were intact.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that a shaft break occurred and was removed by snaring.The target lesion was located in the coronary artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention.During the procedure, it was noted that the device was broken on the shaft before the balloon.The device was removed from the guide catheter in multiple pieces using a snare and the procedure was completed.No patient complications were reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to (b)(6) 2025 as no event date was reported.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22401002
• Report Number: 2124215-2025-43151
• Device Sequence Number: 9664531
• Product Code: NWX
• UDI-Device Identifier: 08714729888277
• UDI-Public: (01)08714729888277(17)251120(10)32902856
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2025
• Device Model Number: H74939401103250
• Device Catalogue Number: H74939401103250
• Device Lot Number: 0032902856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown