BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS

    MDR report key: 1561606 · Received December 17, 2009

    Report

    Report Number
    2015691-2009-12320
    Event Type
    Malfunction
    Date Received
    December 17, 2009
    Date of Event
    October 6, 2009
    Report Date
    October 6, 2009
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORT WAS CONFIRMED. BALLOON DID NOT MAINTAIN INFLATION DUE TO A TEAR/HOLE, 0.06" IN LENGTH, AT THE 41.5 CM AREA ON THE CATHETER BODY, WHICH ENTERED INTO THE INFLATION LUMEN. REST OF THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE. NO VISIBLE DAMAGE TO BALLOON LATEX. THERMISTOR LEAD WIRE INSIDE THE CATHETER BODY WAS NOTED TO BE RIPPLED 68-78 CM AREA, WHICH IS CHARACTERISTIC OF THE CATHETER BODY TO HAVE BEEN STRETCHED. THERMISTOR WAS CONTINUOUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS OBSERVED THAT THE CATHETER AT THE PROXIMAL END OF BALLOON WAS BROKEN AND DIDN'T INFLATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES, PR 831HF75 58728902

    Patients

    Seq Age Sex Outcome Treatment
    1