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	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon burst.The device was removed without any problem using the normal method and the procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes: device analysis findings: the device was returned to the complaint investigation site for analysis.Visual/tactile inspection identified kinks in the hypotube shaft.Microscopic analysis observed distal tip damage (flared).Microscopic analysis also noted that the balloon appeared to have been subjected to positive pressure and blood was present in the balloon.The device was attached to an encore inflation device, and an attempt was then made to inflate the balloon however, pressure was unable to maintained as inflation liquid was observed leaking from a pinhole in the balloon material just proximal to the proximal markerband which was observed microscopically.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: a 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 it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review (prr) table.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 adverse event related to patient condition as it is most likely that anatomical factors (calcified and moderately tortuous vessel) were met which resulted in the reported event.

• 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: 50059188
• Report Number: 2124215-2026-40392
• Device Sequence Number: 10705342
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: (01)08714729888260(17)280112(10)38326499
• 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
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939401103000
• Device Catalogue Number: H74939401103000
• Device Lot Number: 0038326499
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2026
• 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
• Patient Sex: Unknown