MAUDE Adverse Event Report: FIGHTER; CATHETER, GUIDEWIRE

Model Number	2837
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the site report date as the specific date was not provided.
Event or Problem Description
It was reported that a tip detached and remained in the patient.The patient presented or a percutaneous coronary intervention.Vascular access was obtained via the right radial artery.The totally occluded target lesion was located in the anterior descending artery.A flexible metal 6f guide catheter was advanced and the left coronary artery was cannulated.A 190cm, straight-tip fighter guidewire was advanced on this high support coronary angioplasty guide positioning it against the total occlusion but after several attempts the device could not cross the lesion.To optimize support, a 2.00 x 8mm coronary angioplasty balloon was positioned in front of the lesion and torque movements were performed in the angioplasty guide, making it advance to the middle segment.The distal end of the guide fractured and was lodged intravenously by the tissue of the total occlusion.There was no evidence of dissection or rupture of the vessel.The patient was asymptomatic and hemodynamically stable so faced with failure of the percutaneous strategy, the procedure was cancelled.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• MDR Report Key: 12698504
• Report Number: 2134265-2021-12786
• Device Sequence Number: 13793933
• Product Code: DQX
• UDI-Device Identifier: 08714729886617
• UDI-Public: 08714729886617
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 05/09/2024
• Device Model Number: 2837
• Device Catalogue Number: 2837
• Device Lot Number: 0027286616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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