BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET ULTRA SYSTEM

    MDR report key: 1410735 · Received June 30, 2009

    Report

    Report Number
    1410735
    Event Type
    Death
    Date Received
    June 30, 2009
    Date of Event
    May 22, 2009
    Report Date
    June 25, 2009
    Manufacturer
    POSSIS MED, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT THROMBOLYSIS OF LEFT FOREARM DIALYSIS SHUNT TWICE IN 2009. APPROXIMATELY TWO HOURS AFTER PT WAS TRANSFERRED TO MEDICAL FLOOR, HE WAS FOUND PULSELESS. RESUSCITATION EFFORTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET ULTRA SYSTEM THROMBECTOMY SYSTEM MCX POSSIS MED, INC. 5000A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death