BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION

    MDR report key: 22152700 · Received June 5, 2025

    Report

    Report Number
    2124215-2025-32980
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    April 22, 2025
    Report Date
    June 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839415
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K) #: K142259, K163701. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE BATCH/LOT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A DIREXION CATHETER INFUSION WAS SELECTED FOR USE. WHILE INSPECTING AND SHAPING THE TIP OF THE DEVICE, IT FRACTURED AND COULD NO LONGER BE USED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344495 DIREXION CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195300 08714729839415

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown