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

Model Number	3854
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified vessel.A 10mmx3.50mm and a 10mmx3.25mm wolverine coronary cutting balloon were selected for use.During the procedure, the balloon was inserted and blood rushed into the hub.The balloon was removed over the wire and it was noted that the shaft broke in half occurred outside the body.The device was completely removed and intact.The procedure was completed with a different device.No complications were reported and there was no harm to the patient.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was folded.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.The device was received in two sections as a result of a break in the hypotube.The break was located at 58.9cm distal from the strain relief.Both sections of the hypotube were kinked at various locations.This type of damage is consistent with excessive force that could have been applied to the delivery system.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified vessel.A 10mmx3.50mm and a 10mmx3.25mm wolverine coronary cutting balloon were selected for use.During the procedure, the balloon was inserted and blood rushed into the hub.The balloon was removed over the wire and it was noted that the shaft broke in half occurred outside the body.The device was completely removed and intact.The procedure was completed with a different device.No complications were reported and there was no harm to the patient.
Additional Manufacturer Narrative
B1 adverse event/product problem, b2 outcomes attrib to adv event, h1 type of reportable event, h6 impact codes: corrected.Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was folded.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.The device was received in two sections as a result of a break in the hypotube.The break was located at 58.9cm distal from the strain relief.Both sections of the hypotube were kinked at various locations.This type of damage is consistent with excessive force that could have been applied to the delivery system.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the moderately tortuous and moderately calcified vessel.A 10mmx3.50mm and a 10mmx3.25mm wolverine coronary cutting balloon were selected for use.During the procedure, the balloon was inserted and blood rushed into the hub.The balloon was removed over the wire and it was noted that the shaft broke in half occurred outside the body.The device was completely removed and intact.The procedure was completed with a different device.No complications were reported and there was no harm to the patient.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16545436
• Report Number: 2124215-2023-12148
• Device Sequence Number: 6490683
• Product Code: NWX
• UDI-Device Identifier: 08714729888277
• UDI-Public: 08714729888277
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2024
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0030148722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 03/26/2024
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/20/2023; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown