BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS

    MDR report key: 1030814 · Received April 17, 2008

    Report

    Report Number
    6000002-2008-06575
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 29, 2008
    Report Date
    April 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES PC
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE PA PRESSURE OVER DAMPING WAS OBSERVED FROM THE BEGINNING. ANOTHER TRANSDUCER WAS USED BUT THE PROBLEM WAS NOT SOLVED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES PC TS258H5F 58418735

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other