BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL VIP PLATFORM

    MDR report key: 3171979 · Received June 3, 2013

    Report

    Report Number
    3171979
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    FEMORAL ACCESS GAINED WITHOUT ISSUE DURING HEART CATH PROCEDURE. FEMORAL ARTERY VISUALIZED GOOD FOR ANGIOSEAL DEPLOYMENT. ANGIOSEAL DILATOR PLACED IN ANGIOSEAL SHEATH. SECURE "CLICK" HEARD. SHEATH AND DILATOR UNIT ADVANCED OVER LONG .035 WIRE UNTIL BLOOD RETURN INDICATED DEVICE INSIDE VESSEL. DILATOR AND WIRE REMOVED. IT WAS THEN NOTICED THERE WAS A SIGNIFICANT BLOOD BACKFLOW FROM THE ANGIOSEAL SHEATH AS IF THERE WAS NO "RUBBER DAM" TO PREVENT BACKFLOW. ANGIOSEAL DEVICE ADVANCED THROUGH THE SHEATH UNTIL THE SHEATH AND DEVICE CLICKED. ANGIOSEAL DEPLOYED WITHOUT A PROBLEM. HEMOSTASIS ACHIEVED. MANUAL PRESSURE HELD JUST TO BE SAFE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HEART CATH.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244788 ANGIO-SEAL VIP PLATFORM VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL * 4009835

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR