BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1000580 · Received February 15, 2008

    Report

    Report Number
    6000002-2008-06060
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    December 11, 2007
    Report Date
    December 11, 2007
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. EXAMINATION REVEALED THAT LEAKAGE WAS OBSERVED FROM A CUT IN THE BALLOON 0.012 INCHES LONG NEAR THE DISTAL BOND AREA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE. 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 EDWARDS LIFESCIENCES, PR 746HF8 58429275

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other