BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVENT PULMONARY CATHETER

    MDR report key: 1070442 · Received July 1, 2008

    Report

    Report Number
    6000002-2008-07847
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    SALES REP REPORTS THAT DURING A PROCEDURE THE EV WAS NOT VENTING PROPERLY. THERE WAS A SIGNIFICANT AMOUNT OF BACK FILL WITHIN THE HEART. UPON REMOVING THE PRODUCT, PRODUCT TIP WAS "DISENGAGED" FROM THE CANNULA BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVENT PULMONARY CATHETER PULMONARY CATHETER DWF EDWARDS LIFESCIENCES EV MS0408006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other