BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SWAN-GANZ TRUE SIZE MONITORING CATHETER

    MDR report key: 34386 · Received June 24, 1996

    Report

    Report Number
    34386
    Event Type
    Death
    Date Received
    June 24, 1996
    Date of Event
    June 11, 1996
    Report Date
    June 18, 1996
    Manufacturer
    EDWARDS CRITICAL CARE DIV. BAXTER HEALTHCARE CORP.
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED TEAR OF PULMONARY ARTERY DURING DIAGNOSTIC HEART CATHETERIZATION. PT DEVELOPED DISTRESS FOLLOWING ATTEMPTS TO "WEDGE" CATHETER IN PULMONARY ARTERY. AUTOPSY REVEALED PT TO HAVE UNDERLYING DISEASE PLACING HER AT HIGH RISK FOR PULMONARY ARTERY RUPTURE. PT HAD SIGNIFICANT PULMONARY HYPERTENSION AND SEVERE ATHEROSCHLEROTIC DISEASE OF THE PULMONARY VASCULATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SWAN-GANZ TRUE SIZE MONITORING CATHETER PULMONARY ARTERY CATHETER DYG EDWARDS CRITICAL CARE DIV. BAXTER HEALTHCARE CORP. 111F7-7F UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death