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

Model Number	81725
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6)2024.It was reported that guidewire fracture occurred.The patient underwent an embolization procedure.A 200cm x 10cm fathom -14 guidewire was selected for treatment and advanced.When the device was withdrawn, it fractured into pieces.No fragments were left inside the patient.The device was replaced for another of the same model to complete the procedure.There is no further information about whether or not fragments were left inside the patient.No complications were reported, and patient status was stable.It was further reported that there were kink marks on the guidewire but not fractured, and no fragments were left inside the patient.However, returned device analysis revealed that the guidewire was detached, bent, and stretched at distal tip section.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection revealed that the guidewire was bent, detached, and stretched at the distal tip section.In addition, the proximal section was kinked.Based on analysis of the returned device, the allegation of a guidewire kink was 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: 19355468
• Report Number: 2124215-2024-30451
• Device Sequence Number: 7703663
• Product Code: DQX
• UDI-Device Identifier: 08714729801030
• UDI-Public: 08714729801030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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 Expiration Date: 10/01/2026
• Device Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0032548344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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
• Patient Age: 50 YR
• Patient Sex: Male