BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGLIDE

    MDR report key: 2181273 · Received July 21, 2011

    Report

    Report Number
    MW5021486
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ABBOTT
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE - ENDOVASCULAR ABDOMINAL AORTA ANEURYSM REPAIR. WHEN SURGEON ATTEMPTED TO DEPLOY A PERCUTANEOUS PROGLIDE SUTURE CLOSURE DEVICE INTO THE FEMORAL ARTERY TO PERFORM THE PROCEDURE PERCUTANEOUSLY RATHER THAN A CUT DOWN PROCEDURE. DURING THE REMOVAL OF THE CLOSURE SYS, THE SHAFT OF THE DEVICE BROKE IN THE FEMORAL ARTERY. THE SURGEON HAD TO CONVERT TO AN OPEN CUT DOWN PROCEDURE TO REMOVE THE SHAFT OF THE DEVICE. THE COMPLETION AND REPAIR OF THE ABDOMEN ANEURYSM WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGLIDE SUTURE CLOSURE DEVICE MGB ABBOTT 040416H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability