BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1021557 · Received March 24, 2008

    Report

    Report Number
    6000002-2008-06336
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 28, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE CATHETER WAS RECEIVED OPENED IN ITS ORIGINAL PACKAGE. EXAMINATION REVEALED THAT THE BALLOON DID NOT INFLATE DUE TO LEAKAGE FROM THE INFLATION LUMEN NEAR THE DISTAL END OF THERMAL FILAMENT MID-FORM. LEAKAGE OCCURRED FROM A SLIT, ABOUT .03 INCHES LONG AND EXTENDED UNDERNEATH THE THERMAL FILAMENT COVER. A CAPA IS IN PROCESS FOR SLIT IN CATHETER BODY RELATED TO BALLOON INFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE AND BALLOON COULD NOT MAINTAIN INFLATION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 777HF8 58424310

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other