BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 23761449 · Received December 9, 2025

    Report

    Report Number
    2124215-2025-85323
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 12, 2025
    Report Date
    January 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K): K111485, K170636. DEVICE EVAL BY MANUFACTURER: THIS FATHOM-16 GUIDEWIRE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTION REVEALED THAT THE DISTAL TIP WAS KINKED, DETACHED, AND UNRAVELED; HOWEVER, THE DETACHED SEGMENT WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 180 X 25 CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE WAS BROKEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 180 X 25 CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE WAS BROKEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717963 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0037445397 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown