BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION PACEPORT CATHETER

    MDR report key: 1021578 · Received March 24, 2008

    Report

    Report Number
    6000002-2008-06316
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DEFECT WITH THE CATHETER. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION PACEPORT CATHETER THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES, PR 931F75 58345472

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other