BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM -16

    MDR report key: 21647599 · Received March 19, 2025

    Report

    Report Number
    2124215-2025-15477
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 1, 2025
    Report Date
    March 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) #: K111485, K170636.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 180CM X 25CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE IN AN UPPER GASTROINTESTINAL (GI) BLEED NEEDING ANGIOGRAM AND POSSIBLE EMBOLIZATION. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE BROKE OFF. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620497 FATHOM -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0035403223 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male