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

Model Number	H74939401102500
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulty and balloon shaft break occurred resulting in device fragment remaining in the patient.The more than 70% stenosed target lesion was located in the mildly to moderately calcified left main artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.A percutaneous coronary intervention was performed of a left main with existing stents and in-stent restenosis present.After several failed attempts to deliver multiple devices, an undersized non-compliant balloon was successfully delivered to the lesion for dilatation.Subsequently, a 2.5mm wolverine balloon was delivered to the lesion for further dilatation.After inflation, friction was encountered when attempting to remove the device.Negative pressure was applied to the balloon to reduce the device profile which did not aid in removal of the device.Further attempts to remove including sheathing of the device within a guide extension were attempted but failed.Additional traction was applied to the device at which point the balloon became detached from the device shaft.It was decided that entrapping the device to prevent embolization was the safest method to resolve issue.A new stent was placed on top of the broken wolverine to secure it in place and maintain flow to the left coronary system.The device was partially explanted, portion remains implanted, and the procedure was completed using an alternate device.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; 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: 21288068
• Report Number: 2124215-2025-04442
• Device Sequence Number: 9355388
• Product Code: NWX
• UDI-Device Identifier: 08714729888246
• UDI-Public: 08714729888246
• 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
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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 Model Number: H74939401102500
• Device Catalogue Number: H74939401102500
• Device Lot Number: 0035057420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/31/2025
• Date Device Manufactured: 10/14/2024
• 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: 2.0 WOLVERINE; EAGLE EYE IVUS; LASER ATHERECTOMY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown