MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -14; WIRE, GUIDE, CATHETER

Model Number	81725
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 28may2024.It was reported that the guidewire tip was kinked and stretched.The patient underwent mesenteric angiogram for possible bleeding.A 200 cm x 10 cm fathom 14 guidewire was used together with a non-boston scientific (bsc) microcatheter during the procedure.However, angiography revealed that the tip looked kinked, and after removal, the tip looked stretched.The guidewire was removed fully intact through the microcatheter, and another 200 cm x 10 cm fathom -14 guidewire was used.However, the tip of the guidewire was also kinked and stretched.The procedure was completed with alternate wires.However, returned device analysis revealed a detached tip.
Additional Manufacturer Narrative
B3 - date of event: used the first date of the month of bsc aware date as no information was available.Device evaluated by mfr: unit returned with its original pouch, and overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire torquer device and guidewire were returned, and it was observed that the guidewire was bent and stretched at distal tip section.Moreover, it was detached at the tip section.Based on the evidence reported distal tip kinked and distal tip stretched can be confirmed.

• Brand Name: FATHOM -14
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19594926
• Report Number: 2124215-2024-38355
• Device Sequence Number: 12884951
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: 08714729801023
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111498
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2024

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 Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0032938274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: LAMBDA TERUMO
• Patient Sex: Unknown