BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN GANZ CCOMBO PULMONARY ARTERY CATHETER

    MDR report key: 2392817 · Received December 23, 2011

    Report

    Report Number
    MW5023601
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    December 16, 2011
    Report Date
    December 23, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT TO OPERATING FOR AORTIC VALVE REPLACEMENT. PROVIDERS INSERTED THE PAV AND ONCE THEY WERE IN THE PULMONARY ARTERY, THE BALLOON WOULD NOT COME DOWN. THE PAC WAS REMOVED AND WAS FOUND TO BE RUPTURED. A SECOND PAC WAS PLACED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN GANZ CCOMBO PULMONARY ARTERY CATHETER SWAN GANZ CATHETER DYG EDWARDS LIFESCIENCES 59153685

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other