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

Model Number	H74939401103000
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon rupture occurred resulting in patient complications.The 85-90% stenosed target lesion was located in the severely calcified left anterior descending artery.Following use of a 1.25 rota burr, the 10mmx3.00mm wolverine coronary cutting balloon cutting balloon was advanced using guidezilla due to difficulty in advancement.The wolverine was inflated at nominal pressure distal to the calcified lesion.The balloon was inflated a second time directly in the calcified lesion, but the balloon ruptured at 8 atmospheres for 10 seconds, leaving atherectomy bits embedded in the lesion and impossible to retrieve, resulting in dissection and vessel occlusion.No blades were detached.An attempt was made to cover the balloon with the guidezilla, but the guidezilla would not advance.Bailout techniques were carried out with a wire and a parallel, non-boston scientific, balloon, which also ruptured.The guidezilla was advanced with two non-boston scientific wires in the patient successfully covering the devices and everything was retracted from the patient.A stent was implanted to treat the dissection, and the procedure was completed with other devices.There were no further patient complications and the patient fully recovered.

• 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: 23742361
• Report Number: 2124215-2025-88984
• Device Sequence Number: 21384707
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: (01)08714729888260(17)270722(10)37031353
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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: H74939401103000
• Device Catalogue Number: H74939401103000
• Device Lot Number: 0037031353
• 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: 11/13/2025
• Initial Report FDA Received Date: 12/08/2025
• Date Device Manufactured: 07/22/2025
• 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