BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1030546 · Received April 14, 2008

    Report

    Report Number
    6000002-2008-06525
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    December 5, 2007
    Report Date
    December 5, 2007
    Manufacturer
    EDWARD 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. EXAMINATION REVEALED THAT PRIOR TO DECONTAMINATION ALL THROUGH LUMENS WERE PATENT AND THE BALLOON DID NOT INFLATE. AFTER DECONTAMINATION BALLOON LUMEN LEAKAGE WAS OBSERVED THROUGH A SLIT, 0.035 INCHES IN LENGTH, AT THE 12.5 CM AREA (DISTAL OF THE THERMAL FILAMENT). NO VISIBLE DAMAGE TO BALLOON LATEX WAS OBSERVED. 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 THE BALLOON COULD NOT MAINTAIN INFLATION. IT WAS FURTHER STATED THAT LEAKAGE WAS CONFIRMED AT THE 12-13 CM AREA FROM THE TIP DURING LEAK TESTING. NO PT 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 EDWARD LIFESCIENCES, PR 744HF75 58345888

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other