BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION? FATHOM?-16 SYSTEM

    MDR report key: 24292568 · Received February 9, 2026

    Report

    Report Number
    2124215-2026-07138
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839644
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K142259, K163701. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, INITIAL REPORTER, AND PRODUCT RETURN STATUS, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MICROCATHETER FRACTURE OCCURRED. A DIREXION? FATHOM?-16 SYSTEM CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS INTRODUCED INTO THE PATIENT. HOWEVER, THE MICROCATHETER FRACTURED INTO SEVERAL SEGMENTS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352486 DIREXION? FATHOM?-16 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195650 0036578861 08714729839644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown