BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET ULTRA SYSTEM

    MDR report key: 956269 · Received November 29, 2007

    Report

    Report Number
    956269
    Event Type
    Death
    Date Received
    November 29, 2007
    Date of Event
    July 25, 2007
    Report Date
    November 15, 2007
    Manufacturer
    POSSIS MEDICAL INCORP
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT REFUSED PERIPHERAL ACCESS AND INSISTED ON A THROMBECTOMY OF AN A-V GRAFT (ON DIALYSIS) RECURRED MAC FOR THIS PERCUTANEOUS PROCEDURE AS AN EMERGENCY (ASA IVE). HE WAS AWAKE THROUGHOUT THE PROCEDURE UNTIL HE ARRESTED. HE DEVELOPED BRADYCARDIA, AND WAS MONITORED AS THIS OCCURS WITH THE USE OF THE ANGIOJET AUTOPSY REVEALED A MASSIVE POST - VENTRICULAR WALL MI, PROBABLY STARTING 3 DAYS PRIOR TO THE PROCEDURE. AN RCA DONE DID NOT FEEL THAT THE USE OF THE ANGIOJET WAS CAUSE OF ARREST; HOWEVER, AFTER RECEIVING NOTICE ABOUT THE ANGIOJET, IT WAS THOUGHT THAT THIS SHOULD BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET ULTRA SYSTEM AVX THROMBECTOMY SET DXE POSSIS MEDICAL INCORP 105039-001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death