MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	H74939401103500
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon blade was lifted.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal right coronary artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated at 12 atmospheres.During removal, it was fully deflated; however, there was difficulty removing balloon from the guide.One blade did not rewrap and appeared to be sticking out.The procedure was completed using alternate device.There were no complications and patient fully recovered post procedure.
Additional Manufacturer Narrative
Device analysis findings: device evaluated by manufacturer.The complaint device was received for product analysis.A visual and tactile examination of the hypotube shaft noted no issues.A visual and tactile examination of the distal extrusion identified no damages.A detailed microscopic examination of the balloon material identified no tears or pinholes.One blade identified a distal blade segment and blade pad lifted.The remainder of the blades identified no issues and blade pads are intact.Tip showed no signs of tip damage.Examination of the proximal and distal markerbands identified no damage.During leakage test, using an encore inflation unit (tested before and after use with druck pressure gauge g19252), the balloon was inflated to its rated burst pressure (rbp) of 12 atmospheres (atm).The balloon inflated fully and maintained pressure for 15 seconds, with no leaks noted.A vacuum was applied, and the balloon deflated fully with no resistance.No other issues were identified during the product analysis.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.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 it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this product investigation is assigned the most probable cause classification of adverse event related to patient condition as it is likely the patient anatomy contributed to the reported event.This code was selected as the most probable complaint cause based on the information available and the condition of the returned device.
Event or Problem Description
It was reported that the balloon blade was lifted.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal right coronary artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated at 12 atmospheres.During removal, it was fully deflated; however, there was difficulty removing balloon from the guide.One blade did not rewrap and appeared to be sticking out.The procedure was completed using alternate device.There were no complications and patient fully recovered post procedure.

• 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 ; 7634941632
• MDR Report Key: 24370067
• Report Number: 2124215-2026-08929
• Device Sequence Number: 14671618
• Product Code: NWX
• UDI-Device Identifier: 08714729888284
• UDI-Public: (01)08714729888284(17)271017(10)37731081
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: H74939401103500
• Device Catalogue Number: H74939401103500
• Device Lot Number: 0037731081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown