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 Code Available (3191)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The chronic totally occluded target lesion was located in the right coronary artery which was fully stented.The occlusion was at the proximal end of the stent.A 190cm, straight-tip fighter guidewire was advanced with a turnpike in an attempt to cross the lesion; however, the tip of the wire sheared off.The detached tip was successfully removed by trapping the tip of the wire inside the guide with a balloon.There were no patient complications nor injuries reported.Additional wires were attempted to be used, but the procedure was unsuccessful.
Additional Manufacturer Narrative
Device evaluated by mfr.: fighter, 190cm, straight-tip (5pk) was received for analysis.Examination of the returned product showed a curve over a length of 30 mm from the distal tip, and no other abnormalities.
Event or Problem Description
It was reported that tip detachment occurred.The chronic totally occluded target lesion was located in the right coronary artery which was fully stented.The occlusion was at the proximal end of the stent.A 190cm, straight-tip fighter guidewire was advanced with a turnpike in an attempt to cross the lesion; however, the tip of the wire sheared off.The detached tip was successfully removed by trapping the tip of the wire inside the guide with a balloon.There were no patient complications nor injuries reported.It was reported that tip detachment occurred.It was further reported that the procedure was aborted because the physician was unable to successfully cross the chronic total occlusion.
Event or Problem Description
It was reported that tip detachment occurred.The chronic totally occluded target lesion was located in the right coronary artery which was fully stented.The occlusion was at the proximal end of the stent.A 190cm, straight-tip fighter guidewire was advanced with a turnpike in an attempt to cross the lesion; however, the tip of the wire sheared off.The detached tip was successfully removed by trapping the tip of the wire inside the guide with a balloon.There were no patient complications nor injuries reported.It was further reported that the procedure was aborted because the physician was unable to successfully cross the chronic total occlusion.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10106207
• Report Number: 2134265-2020-07254
• Device Sequence Number: 3016929
• Product Code: DQX
• UDI-Device Identifier: 08714729886617
• UDI-Public: 08714729886617
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2020

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: 11/29/2022
• Device Model Number: 2837
• Device Catalogue Number: 2837
• Device Lot Number: 0024851514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 06/23/2020; 08/20/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/30/2020; 08/25/2020
• 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