BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION? HI-FLO?

    MDR report key: 24434571 · Received February 24, 2026

    Report

    Report Number
    2124215-2026-10243
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839507
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 COATING ISSUE OCCURRED. A DIREXION HI-FLO CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER STRIPPED. 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
    494190 DIREXION? HI-FLO? CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195430 0037104520 08714729839507

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown