BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1220804 · Received October 30, 2008

    Report

    Report Number
    6000002-2008-09130
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER REPORT WAS CONFIRMED. THE CATHETER BODY WAS FOUND TO HAVE WHAT APPEARS TO BE A SCRAPE 52CM PROXIMAL OF THE CATHETER TIP. THE SCRAPE HAS ALSO ENTERED THE THERMAL FILAMENT LEAD WIRE LUMEN. THE CATHETER BODY HAS WHAT APPEARS TO BE ADHESIVE (HARD AND CLEAR) 62 CM PROXIMAL OF THE CATHETER TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ">" SHAPE DAMAGE OBSERVED AT THE 52CM FROM THE TIP OF THE CATHETER BODY. THERE WAS ALSO ADHESIVE LIKE MATERIAL FOUND AT 62CM FROM THE TIP OF THE CATHETER.

    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 58549841

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other