BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGLIDE

    MDR report key: 3110818 · Received April 25, 2013

    Report

    Report Number
    3110818
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME IN WITH NSTEMI. WENT TO CATH LAB FOR A CORONARY STENT PLACEMENT. USED CLOSURE DEVICE AND IT BECAME STUCK INSIDE OF THE PATIENT; COULD NOT GET IT REMOVED. PATIENT WAS TAKEN EMERGENTLY TO THE OR WHERE THEY REMOVED THE DEVICE AND REPAIRED THE FEMORAL ARTERY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PCI TO RCA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178590 PROGLIDE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT LABORATORIES * 30227K1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O| R