BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVX THROMBECTOMY SET

    MDR report key: 16950050 · Received May 17, 2023

    Report

    Report Number
    2124215-2023-23884
    Event Type
    Death
    Date Received
    May 17, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DIED DUE TO CARDIAC ARREST. IN 2022, THE PATIENT WAS REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION TWO TIMES, FOR CHRONIC KIDNEY DISEASE. TWO TO THREE DAYS BEFORE THE PROCEDURE, THE PATIENT RECEIVED DIALYSIS TREATMENT. THE TARGET LESION WAS LOCATED IN THE LEFT BRACHIOCEPHALIC VEIN. AN ANGIOGET AVX CATHETER WAS SELECTED FOR AN ARTERIOVENOUS FISTULA THROMBECTOMY AND 10ML OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WITH 250ML OF NORMAL SALINE, WAS USED IN THE PROCEDURE. THROMBECTOMY WAS PERFORMED FOR 300 SECONDS, WHEN USE OF THE DEVICE WAS STOPPED, DUE TO POOR CONDITION OF THE PATIENT AND LOW BLOOD PRESSURE. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT WAS MOVED TO THE EMERGENCY ROOM AND LATER DIED DUE TO CARDIAC ARREST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DIED. IN 2022, THE PATIENT WAS REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION TWICE FOR CHRONIC KIDNEY DISEASES. TWO TO THREE DAYS AGO, BEFORE THE PROCEDURE, THE PATIENT WAS RECEIVING DIALYSIS TREATMENT. THE TARGET LESION WAS LOCATED IN THE LEFT BRACHIOCEPHALIC VEIN. AN ANGIOGET AVX CATHETER WAS SELECTED FOR ARTERIOVENOUS FISTULA THROMBECTOMY AND USES 10ML OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WITH NS 250ML FOR MEDICATION. THE DEVICE WAS RUN FOR 300 SECONDS OF THROMBECTOMY; OPERATOR STOPPED USING THE DEVICE DUE TO POOR CONDITION OF THE PATIENT AND BLOOD PRESSURE WAS LOW. AFTER THE PROCEDURE WAS COMPLETED, AND FEW MINUTES LATER OF RECOVERY, THE PATIENT WAS MOVED TO ER AND EVENTUALLY DIED DUE TO CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696552 AVX THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0030934867

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death