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

Model Number	2832
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation (2001); Foreign Body In Patient (2687)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that distal tip detachment and perforation occurred.The patient was presented with chronic total occlusion (cto) and underwent percutaneous coronary intervention.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified mid to distal left anterior descending artery (lad).A 190cm, straight-tip fighter guidewire was advanced for treatment.However, while trying to cross the lesion, the wire was lodged in the calcium.When an attempt was made to pull back the wire, the tip came off and could not be recovered.The radiopaque portion of the wire was left in the body but was secured between the vessel and the calcium.It was then noted that perforation occurred in the septal branch of the lad.Subsequently, stat echocardiogram and final angiogram were performed to ensure the perforation was contained.The procedure was not completed and no further patient complications were reported.The patient was stable and was fully recovered post procedure.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16808582
• Report Number: 2124215-2023-17825
• Device Sequence Number: 12270573
• Product Code: DQX
• UDI-Device Identifier: 08714729887676
• UDI-Public: 08714729887676
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: 08/26/2023
• Device Model Number: 2832
• Device Catalogue Number: 2832
• Device Lot Number: 0025924307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• 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: Other
• Patient Sex: Unknown