BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 3844962 · Received May 19, 2014

    Report

    Report Number
    3844962
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ABBOTT VASCULAR, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER THE CATHETERIZATION A PROGLIDE WAS USED TO CLOSE THE ACCESS POINT. WHEN THE DEVICE WAS ATTEMPTED TO DEPLOY IT MALFUNCTIONED AND WOULD NOT DEPLOY AND WAS NOT ABLE TO BE PULLED OUT OF THE PATIENT. CUSTOMER SERVICE FOR THE DEVICE WAS CONTACTED ABOUT THE ISSUE AND WITH THEIR HELP THE DEVICE WAS ULTIMATELY REMOVED FROM THE PATIENT WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295751 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR, INC. * 40128R1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR