BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION FATHOM-16 SYSTEM

    MDR report key: 20429057 · Received October 11, 2024

    Report

    Report Number
    2124215-2024-63628
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839668
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A DIREXION FATHOM-16 SYSTEM WAS USE FOR GENICULAR ARTERY EMBOLIZATION(GAE). DURING THE PROCEDURE, THE DIREXION CATHETER WAS NOT FUNCTIONING AS EXPECTED. UPON REMOVAL, THE CATHETER WAS FOUND TO BE BROKEN ABOUT 5 INCHES FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313800 DIREXION FATHOM-16 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION 84592 0034346473 08714729839668

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown