MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FIGHTER; CATHETER, GUIDEWIRE

Model Number	2837
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire fracture occurred.The chronic totally occluded target lesion was located in the left anterior descending artery.A 190cm, straight-tip fighter guide wire was advanced to cross the lesion.However, it was noted that the wire broke from the distal tip to the proximal radiopaque.The device was successfully removed with a snare.No patient complications were reported and patient's status was good.
Additional Manufacturer Narrative
The device was returned for analysis.Examination of the returned product revealed that both the coil and the core wire were severed at approximately 35mm from the distal tip, and there was the pitch misalignment in the coil at 95 mm from the distal tip.
Event or Problem Description
It was reported that guide wire fracture occurred.The chronic totally occluded target lesion was located in the left anterior descending artery.A 190cm, straight-tip fighter guide wire was advanced to cross the lesion.However, it was noted that the wire broke from the distal tip to the proximal radiopaque.The device was successfully removed with a snare.No patient complications were reported and patient's status was good.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11474761
• Report Number: 2134265-2021-02768
• Device Sequence Number: 19802672
• Product Code: DQX
• UDI-Device Identifier: 08714729886617
• UDI-Public: 08714729886617
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 09/11/2023
• Device Model Number: 2837
• Device Catalogue Number: 2837
• Device Lot Number: 0026005078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention