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

Model Number	H74939401153000
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon wires broke apart.A two 15mmx3.00mm wolverine coronary cutting balloon were selected for treatment.During the procedure it was noted that the balloon wires broke apart.Removal of the wire percutaneously were unsuccessful.An incision had to be made to remove the broken wires.There was no patient complications reported.It was further reported that this case was reported in medwatch# mw5190435.
Event or Problem Description
It was reported that the balloon wires broke apart.A two 15mmx3.00mm wolverine coronary cutting balloon were selected for treatment.During the procedure it was noted that the balloon wires broke apart.Removal of the wire percutaneously were unsuccessful.An incision had to be made to remove the broken wires.There were no patient complications reported.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed and confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of cause not established.During the procedure it was noted that the two balloon wires broke apart and an incision had to be made to remove both wires.The device was not returned for analysis.Based on the limited information provided a clear conclusion of the reported event cannot be determined.
Additional Manufacturer Narrative
B3 date of event was estimated based on aware date and it being reported that the event took place the week prior.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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: 50059135
• Report Number: 2124215-2026-40385
• Device Sequence Number: 10730574
• Product Code: NWX
• UDI-Device Identifier: 08714729888352
• UDI-Public: (01)08714729888352(17)280420(10)39145275
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939401153000
• Device Catalogue Number: H74939401153000
• Device Lot Number: 0039145275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 04/21/2026
• 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 Sex: Male