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

Model Number	2832
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.A 190cm, straight-tip fighter guidewire was selected for use.However, upon unpacking, the guidewire bent and the guidewire tip fractured.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that guide wire fracture occurred.A 190cm, straight-tip fighter guide wire was selected for use.However, upon unpacking, the guide wire bent and the guide wire tip fractured.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluation by mfr: a kink at about 2mm and a kink 10mm from the distal tip were observed through examination of the returned product.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11268177
• Report Number: 2134265-2021-00689
• Device Sequence Number: 1283440
• Product Code: DQX
• UDI-Device Identifier: 08714729887676
• UDI-Public: 08714729887676
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/26/2021

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: 06/04/2023
• Device Model Number: 2832
• Device Catalogue Number: 2832
• Device Lot Number: 0025565606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1