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

Model Number	H74939401102750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the catheter shaft broke while delivering and was able to remove in two pieces without snaring.The procedure was completed with an alternative device.No patient complications reported.
Event or Problem Description
It was reported that a shaft break occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the catheter shaft broke while delivering and was able to remove in two pieces without snaring.The procedure was completed with an alternative device.No patient complications reported.It was further reported that the device broke along proximal end of the shaft close to the hub outside of the body while trying to cross the lesion and the fractured pieces did not enter the patient's body.After fracturing, the shaft was removed in one piece.The other piece was outside of the body, so technically not removed.

• 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: 22649972
• Report Number: 2124215-2025-51542
• Device Sequence Number: 8632599
• Product Code: NWX
• UDI-Device Identifier: 08714729888253
• UDI-Public: (01)08714729888253(17)270306(10)36008172
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/26/2025

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 Model Number: H74939401102750
• Device Catalogue Number: H74939401102750
• Device Lot Number: 0036008172
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 03/06/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown