BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION?

    MDR report key: 23817174 · Received December 16, 2025

    Report

    Report Number
    2124215-2025-91055
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 26, 2025
    Report Date
    January 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839453
    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.

    Additional Manufacturer Narrative · 0

    B5 - DESCRIBE EVENT OR PROBLEM SECTION UPDATED WITH ADDITIONAL INFORMATION. (B)(6). G4 - PREMARKET / 510(K) #: K142259, K163701.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). HOWEVER, DURING COIL ADVANCING, A FRACTURE OCCURRED AT THE CONNECTION POINT OF THE MICROCATHETER'S DISTAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). HOWEVER, DURING COIL ADVANCING, A FRACTURE OCCURRED AT THE CONNECTION POINT OF THE MICROCATHETER'S DISTAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE ROTATION AT THE END FRACTURED. NO FRACTURED DEVICE WAS INSIDE THE PATIENT BECAUSE IT WAS COMPLETELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377 DIREXION? CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195340 0036116251 08714729839453

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male