BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2222325 · Received August 24, 2011

    Report

    Report Number
    2015691-2011-16098
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    KRA
    PMA / PMN Number
    K924661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED HOSPITAL. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HOLES ON THE CATHETER. THE CATHETER WAS PLACED AND FLOATED IN THE PATIENT IN SURGERY, THEN PATIENT WAS SENT TO SICU. THE DIRECTOR OF THE FLOOR STATED THAT THERE SEEMED TO BE A HOLE IN THE CATHETER DUE TO AIR BEING RELEASED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THERE WAS NO FURTHER INFORMATION THAT THE CUSTOMER COULD PROVIDE. IT WAS STATED THAT TIME HAD PAST AND THE CLINICIANS HAD "MOVED ON". THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD CONTINOUS CARDIAC OUPTUT THERMODILUTION CATHETER KRA EDWARDS LIFESCIENCES, PR 139HF75 58984685

    Patients

    Seq Age Sex Outcome Treatment
    1