BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE

    MDR report key: 4945360 · Received July 9, 2015

    Report

    Report Number
    4945360
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 24, 2015
    Report Date
    July 1, 2015
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ENDOPLEGE CATHETER FUNCTIONED NORMALLY THROUGHOUT THE ENTIRE SURGICAL CASE. IT DELIVERED RETROGRADE CARDIOPLEGIA APPROPRIATELY, INDICATING THE BALLOON WAS PROPERLY INFLATED DURING CARDIOPLEGIA ADMINISTRATION. AT THE END OF THE SURGICAL CASE, IT WAS REMOVED FROM THE CENTRAL VENOUS INTRODUCER IN THE RIGHT INTERNAL JUGULAR VEIN. WHEN REMOVED, IT WAS DISCOVERED THAT THE BALLOON WAS RUPTURED. IT PASSES BOTH AIR AND FLUID THROUGH IT. THIS WAS REPORTED TO THE INTENDED SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447297 PROPLEGE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPA DWF EDWARDS LIFESCIENCES LLC PR9 60044541

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR OTHER| CARDIAC DRUGS