BEUDAMED
    FDA Adverse Event Summary report: N

    SWAN GANZ

    MDR report key: 903053 · Received August 10, 2007

    Report

    Report Number
    903053
    Date Received
    August 10, 2007
    Date of Event
    July 27, 2007
    Report Date
    August 10, 2007
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    DYG
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE EDWARDS LIFESCIENCES, LLC LATEX-FREE SWAN GANZ CATHETER WAS INSERTED THROUGH A 7 FRENCH VENOUS SHEATH. AFTER INSERTION, THE BALLOON RUPTURED IN THE INFERIOR VENA CAVA WHEN IT WAS INFLATED. THIS HAPPENED WITH TWO DIFFERENT CATHETERS. THE BOX IS LABELED THAT THE SWAN GANZ'S SIZE IS 7 FRENCH, BUT WHEN YOU READ BOOKLET, IT STATES THE MINIMUM INTRODUCER SIZE SHOULD BE 8.5 FRENCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN GANZ CATHETER, THERMODILUTION DYG EDWARDS LIFESCIENCES, LLC C146F7 236K0462

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR