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

Model Number	81725
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire was stretched and detached.A 200 cm x 10 cm fathom-14 was selected for a procedure.During use, however, the wire stretched and seemed to fall apart while attempting to direct it inside the patient.The wire was able to be removed, and an alternate method was used to complete the procedure.The procedure had been completed successfully.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the guidewire was returned, and it was observed that it was bent, stretched and detached at distal tip.Based on the evidence, the as reported codes guidewire detachment of device or device component and distal tip stretched can be confirmed, since the detached and stretched found during the product inspection could have contributed to the reported issue.
Event or Problem Description
It was reported that the guidewire was stretched and detached.A 200 cm x 10 cm fathom-14 was selected for a procedure.During use, however, the wire stretched and seemed to fall apart while attempting to direct it inside the patient.The wire was able to be removed, and an alternate method was used to complete the procedure.The procedure had been completed successfully.There were no patient complications reported.

• 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: 20345125
• Report Number: 2124215-2024-60487
• Device Sequence Number: 7945441
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: 08714729801023
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 0033959142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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 Sex: Unknown