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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection type c occurred.The patient was on a prior regimen of aspirin (>= 72 hours).Before the procedure, the patient received heparin or other antithrombotic medication and a loading dose of 81 mg of aspirin.The 2.5 mm x 40 mm target lesion located at the proximal circumflex vessel was pretreated with two devices using the largest balloon diameter 3.0 mm x 30 mm wolverine cutting balloon and semi-compliant balloon angioplasty catheter resulting in 10% residual stenosis and timi flow of 3.The target lesion was then successfully implanted with a 2.5 mm x 38 mm synergy xd stent achieving 10% stenosis and timi flow 3.During the same day of the procedure, it was discovered that post-treatment with the 3.0 mm x 30 mm wolverine cutting balloon and semi-compliant balloon angioplasty catheter a grade c dissection with a dissection length of 4.21 mm and dissection stenosis of 34.09% in segment with timi flow 3.No dissection was noted post treatment with the 2.50 mm x 38 mm synergy xd drug eluting stent.The non-target lesion located at the mid-left anterior descending vessel was also treated prior to the target lesion procedure.It was successfully treated with a 3.0 mm x 20 mm, 3.50 mm x 20 mm and 3.0 mm x 12 mm balloon angioplasty catheters and 3.0 mm x 38 mm of drug eluting stent.The patient was started on aspirin and clopidogrel.
Additional Manufacturer Narrative
D4 unique identifier (udi) number: 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 product is unknown, we are unable to provide the unique identifier (udi) number 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50057669
• Report Number: 2124215-2026-40354
• Device Sequence Number: 10657194
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: (01)08714729888260(17)280413(10)39076258
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/24/2026

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: H74939401103000
• Device Catalogue Number: H74939401103000
• Device Lot Number: 0039076258
• 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: 07/03/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 04/14/2026
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: White