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

Model Number	H74939401154000
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft broke.The 72% stenosed target lesion was located in the mildly tortuous and fibrotic artery.A 15mmx4.00mm wolverine coronary cutting balloon monorail was selected for percutaneous coronary intervention.During the procedure, it was noted that the balloon was difficult to cross and while pushing, the shaft broke while inside the guide catheter.The balloon was removed from the patient's body in two pieces and the procedure was completed with a different device.No complications were reported.
Event or Problem Description
It was reported that the shaft broke.The 72% stenosed target lesion was located in the mildly tortuous and fibrotic artery.A 15mmx4.00mm wolverine coronary cutting balloon monorail was selected for percutaneous coronary intervention.During the procedure, it was noted that the balloon was difficult to cross and while pushing, the shaft broke while inside the guide catheter.The balloon was removed from the patient's body in two pieces and the procedure was completed with a different device.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination revealed a hypotube break was noted at 35cm distal to the distal end of the strain relief.Multiple kinks were also noted.No kinks or damages were noted at the polymer shaft.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Tip showed no signs of tip damage.All blades were fully bonded on the balloon and did not exhibit any signs of damage.

• 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: 21026872
• Report Number: 2124215-2024-82115
• Device Sequence Number: 13038278
• Product Code: NWX
• UDI-Device Identifier: 08714729888390
• UDI-Public: 08714729888390
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/29/2025

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 Expiration Date: 07/03/2026
• Device Model Number: H74939401154000
• Device Catalogue Number: H74939401154000
• Device Lot Number: 0034364593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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