BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION? HI-FLO? TRANSEND?-18 SYSTEM

    MDR report key: 25174324 · Received May 14, 2026

    Report

    Report Number
    2124215-2026-26127
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    January 22, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839842
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. E1: INITIAL REPORTER PHONE: (B)(6). G4: PREMARKET / 510(K) #: K142259, K163701.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE LIVER. A NGMC/TRANSEND/027/BERN/1RO/130 DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THE DEVICE WAS FRACTURED AND UNUSED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612434 DIREXION? HI-FLO? TRANSEND?-18 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195940 0036796843 08714729839842

    Patients

    Seq Age Sex Outcome Treatment
    1