BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION TRANSEND-14 SYSTEM

    MDR report key: 21733908 · Received March 31, 2025

    Report

    Report Number
    2124215-2025-19344
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    February 25, 2025
    Report Date
    May 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839774
    PMA / PMN Number
    K1422599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4-PREMARKET / 510(K) #: K142259, K163701.

    Additional Manufacturer Narrative · 0

    G4-PREMARKET / 510(K) #: K142259, K163701. DEVICE EVALUATED BY MFR: THE DIREXION WAS RETURNED FOR ANALYSIS. THE RETURNED DEVICE CONSISTS OF THE DIREXION AS 2 PIECES. VISUAL AND MICROSCOPIC EXAMINATION REVEALED NICKEL SHAFT FRACTURE LOCATED APPROXIMATELY 8.5CM FROM STRAIN RELIEF. THE INNER LUMEN WAS SEPARATED FROM THE LUER. INNER LUMEN IS STRETCHED APPROXIMATELY 1.5CM FROM THE PURPLE LINER TO PROXIMAL END. NO DAMAGE TO THE REMAINING SHAFT DISTAL TO THE FRACTURE OR TIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) IN THE LIVER. DURING THE PROCEDURE, THE MICROCATHETER WAS INSERTED INTO THE BLOOD VESSEL FOR NORMAL OPERATION. UPON WITHDRAWAL FROM THE BLOOD VESSEL, IT WAS FOUND THAT THE FRONT END OF THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. A DIREXION TRANSEND-14 SYSTEM WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) IN THE LIVER. DURING THE PROCEDURE, THE MICROCATHETER WAS INSERTED INTO THE BLOOD VESSEL FOR NORMAL OPERATION. UPON WITHDRAWAL FROM THE BLOOD VESSEL, IT WAS FOUND THAT THE FRONT END OF THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010210 DIREXION TRANSEND-14 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195840 0035095032 08714729839774

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male