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 Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft got fractured.The target lesion was located in the moderately calcified artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, a resistance was felt upon advancing the device through the guide extension catheter.When the device was pulled out, it was noted that the shaft was fractured.The procedure was completed with an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the wolverine catheter was returned for analysis.A visual and tactile examination of the hypotube identified a break at 18.8cm distal from the strain relief and multiple kinks along the shaft of the device.A visual and tactile examination of the shaft polymer extrusion identified no issues.Microscopic analysis revealed no tears were visible on the balloon material.All blades were intact within their pads and fully bonded to the balloon material.The markerbands/tip were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.As a result of the break and kinks it was not possible to place the device under vacuum, in order to test the device for passage through a recommended 5 french size sheath.Device analysis confirmed a break and multiple kinking had occurred in the hypotube, confirming the reported event.
Event or Problem Description
It was reported that the shaft got fractured.The target lesion was located in the moderately calcified artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, a resistance was felt upon advancing the device through the guide extension catheter.When the device was pulled out, it was noted that the shaft was fractured.The procedure was completed with an alternate device.No patient complications were reported.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16946497
• Report Number: 2124215-2023-22748
• Device Sequence Number: 11358278
• Product Code: NWX
• UDI-Device Identifier: 08714729888277
• UDI-Public: 08714729888277
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/10/2023

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: 09/23/2023
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0028071669
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• 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