BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 12561856 · Received October 1, 2021

    Report

    Report Number
    2134265-2021-12261
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889045
    PMA / PMN Number
    K133629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOSS OF ASPIRATION. AN ANGIOJET AVX WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WERE SUCTION ISSUES WITH THE SYSTEM AND THE PUMP WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457384 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0027805629 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1