BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMODILUTION CATHETER

    MDR report key: 14625 · Received March 23, 1994

    Report

    Report Number
    14625
    Event Type
    Death
    Date Received
    March 23, 1994
    Date of Event
    March 8, 1994
    Report Date
    March 22, 1994
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 68-YR-OLD FEMALE ADMITTED WITH DIAGNOSIS OF MITRAL STENOSIS, WAS TO HAVE CARDIAC CATHETERIZATION TO EVALUATE FOR POSSIBLE MITRAL VALVE REPLACEMENT. PRIOR TO ACTUAL PROCEDURE, THE CARDIOLOGIST HAD DIFFICULTY WITH CATHETER PLACEMENT. EVENTUALLY USED S-SHAPED CATHETER WITH GUIDE WIRE. ALMOST IMMEDIATELY AFTER PLACEMENT OF THIS CATHETER, PT HAD COUGHING EPISODE OF LARGE AMOUNT OF BRIGHT RED BLOOD. WENT INTO CARDIAC ARREST AND EXPIRED DESPITE ACLS PROTOCOL FOR ONE HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMODILUTION CATHETER THERMODILUTION CATHETER DYG ABBOTT LABORATORIES 41227-01 77-014-SNO 1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death