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

Model Number	H74939401104000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blades were opened.The target lesion was located in the coronary artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During preparation, at removal from the package, the physician observed that the blades appeared winged/opened.During use, the balloon was unable to cross through the 6f guide catheter.The procedure was completed with another of the same device.There were no patient complications, and the patient was in good condition after the procedure.
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 conclusion code of failure to follow instructions based on the user not having applied negative pressure to the balloon prior to the removal of the balloon protector.This code was selected as the most probable complaint cause based on the information.Based on the event description, the user removed the balloon protector prior to applying a vacuum.The user is to apply negative pressure when the device is in its protective hoop, see step 2 'using sterile technique, remove the device in its protective hoop from its package and place onto a sterile field.Do not remove the device from its protective hoop.Do not remove the balloon protector from the device tip.'.

• 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
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50245618
• Report Number: 2124215-2026-43596
• Device Sequence Number: 10169099
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: (01)08714729888307
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/17/2026

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: H74939401104000
• Device Catalogue Number: H74939401104000
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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