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

Model Number	2837
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the moderate to severely calcified left anterior descending artery.A 190cm, straight-tip fighter guidewire was selected for use.However, during unpacking, a breakage in the device was noted.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the moderate to severely calcified left anterior descending artery.A 190cm, straight-tip fighter guidewire was selected for use.However, during unpacking, a breakage in the device was noted.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.It was further reported that the device was not fractured as what was previously reported.The device was just kinked upon unpacking.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the moderate to severely calcified left anterior descending artery.A 190cm, straight-tip fighter guidewire was selected for use.However, during unpacking, a breakage in the device was noted.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.It was further reported that the device was not fractured as what was previously reported.The device was just kinked upon unpacking.
Additional Manufacturer Narrative
Device evaluated by mfr.: as a result of observing the returned product, bends were confirmed at about 1 mm and 27 mm from the distal tip of the wire.In addition, a kink (inner angle of about 124 degrees) was confirmed at about 1778 mm from the distal tip of the wire were confirmed.No other abnormalities were observed.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15510453
• Report Number: 2124215-2022-37510
• Device Sequence Number: 6041166
• Product Code: DQX
• UDI-Device Identifier: 08714729886617
• UDI-Public: 08714729886617
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2022

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: 11/29/2022
• Device Model Number: 2837
• Device Catalogue Number: 2837
• Device Lot Number: 0024851369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 09/29/2022; 11/23/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/10/2022; 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2019
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 58 KG