BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE

    MDR report key: 3804286 · Received April 14, 2014

    Report

    Report Number
    3804286
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    June 17, 2013
    Report Date
    April 14, 2014
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE DID NOT DEPLOY CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228008 PERCLOSE PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673 30419K1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR