BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM -16

    MDR report key: 20846345 · Received December 4, 2024

    Report

    Report Number
    2124215-2024-75692
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 19, 2024
    Report Date
    December 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - ADDITIONAL PREMARKET / 510(K): K170636.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT HEPATIC ARTERY. A 180X25CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS FRACTURED. THE WIRE WAS REMOVED ALONG WITH THE MICROCATHETER. THE PROCEDURE TIME WAS PROLONGED AND WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050678 FATHOM -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0034972381 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown