MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Wolverine Coronary Cutting Balloon; catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Model Number	H74939401062500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vasospasm (2128); Vascular Dissection (3160)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complications occurred.The patient presented for planned percutaneous coronary intervention.The 80% in-stent restenosed target lesion was located from the mid to distal lad.The target lesion was pre-treated with a 2.50 x 6 mm wolverine cutting balloon.Following pre-treatment with the wolverine balloon, a dissection and spasm were observed and were treated with nitroglycerin and a 2.00 x 12 mm agent dcb balloon inflated to 4 atm.After treatment with the agent dcb, the angiographic appearance normalized.The lesion was then successfully treated with additional 3.00 x 12 mm and 2.50 x 20 mm agent dcb devices.The patient tolerated the procedure well and was discharged home in stable condition.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the specific product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.

• 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 ; +1(612)875-7234
• MDR Report Key: 50246804
• Report Number: 2124215-2026-43651
• Device Sequence Number: 13279470
• Product Code: NWX
• UDI-Device Identifier: 08714729888154
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: H74939401062500
• Device Catalogue Number: H74939401062500
• 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: 07/23/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/10/2026
• 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 Age: 33 YR
• Patient Sex: Male
• Patient Race: White