BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMBOLEX

    MDR report key: 24699329 · Received March 26, 2026

    Report

    Report Number
    3015489145-2026-00006
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 25, 2026
    Manufacturer
    THROMBOLEX, INC.
    Product Code
    QEY
    PMA / PMN Number
    K231653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO CORRECTIVE/PREVENTIVE ACTIONS IN PROCESS.

    Description of Event or Problem · 0

    IT WAS OBSERVED, FOLLOWING DEVICE INSERTION INTO THE PATIENT, THAT WHILE ATTEMPTING TO INFUSE, THE DEVICE WOULD NOT FLUSH FLUID THROUGH THE INFUSION HOLES IN THE BASKET. NO PATIENT HARM. DEVICE WAS REPLACED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351785 THROMBOLEX BASHIR .035 ENDOVASCULAR CATHETER QEY THROMBOLEX, INC. 8201 343453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female