BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION? FATHOM?-16 SYSTEM

    MDR report key: 22437245 · Received July 8, 2025

    Report

    Report Number
    2124215-2025-44396
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    April 16, 2025
    Report Date
    July 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839637
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K142259, K163701.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A DIREXION FATHOM -16 SYSTEM WAS USED FOR TREATMENT. DURING THE PROCEDURE, DEHISCENCE OF THE MICROCATHETER WAS NOTED. AT THIS POINT, ONLY A SMALL AMOUNT OF THE DRUG WAS LEFT IN THE MICROCATHETER. SUBSEQUENTLY, THE MICROCATHETER SYSTEM WAS WITHDRAWN, AND THE PROCEDURE WAS DISCONTINUED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340651 DIREXION? FATHOM?-16 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195640 0034463851 08714729839637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown