BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION? TRANSEND?-14 SYSTEM

    MDR report key: 24507836 · Received March 4, 2026

    Report

    Report Number
    2124215-2026-12067
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839774
    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 ADDRESS 1: (B)(6). E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET/510(K) #: K142259, K163701.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MALIGNANT NEOPLASM OF RECTUM. A DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, A FRACTURE WAS FOUND 10 CM AFTER ENTERING THE VESSEL. 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
    298571 DIREXION? TRANSEND?-14 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195840 0036990678 08714729839774

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female