BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION? HI-FLO?

    MDR report key: 25280116 · Received May 26, 2026

    Report

    Report Number
    2124215-2026-28140
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839484
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    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, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT DETACHED OCCURRED. A NGMC/SINGLE/027/STRAIGHT/1RO/130 DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER WAS SHEARED. THE PHYSICIAN OBSERVED THAT COIL ADVANCEMENT HAD BEEN SLUGGISH EARLIER. WHEN ATTEMPTING TO PULL BACK MICRO CATHETER, IT BEGAN TO SPLIT AND COULD NOT BE REMOVED. AFTER THE COIL WAS RETRIEVED, THE MICROCATHETER SNAPPED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98693 DIREXION? HI-FLO? CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195410 0038667794 08714729839484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown