BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUIDANT ARIES CO2 BLOWER/MISTER

    MDR report key: 658210 · Received December 27, 2005

    Report

    Report Number
    2953148-2005-01083
    Event Type
    Death
    Date Received
    December 27, 2005
    Date of Event
    November 16, 2005
    Report Date
    November 29, 2005
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    FQH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED IN 11/2005 THAT DURING AN OFF PUMP PROCEDURE PERFORMED ABOUT 2 WEEKS EARLIER, THE BLOWER/MISTER CAUSED THE OBTUSE MARGINAL CORONARY ARTERY (OMI) TO DISSECT. THE SURGEON REPAIRED THE DISSECTION AND USED A 1.5MM SHUNT. THE PT DEVELOPED A POST-OP MI CARDIOGENIC SHOCK TWO HOURS AFTER SURGERY IN THE ICU. THE PT WAS TAKEN BACK TO OR AND FOUND THE SVG TO OM GRAFT HAD THROMBOSED. THE GRAFT WAS RE-DONE IN CARDIOPULMONARY BYPASS. THE PT DIED IN ICU ABOUT 6 HRS. LATER. THE DR MENTIONED THAT HE COULD NOT ACHIEVE THE DESIRABLE BLOW/MIST FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT ARIES CO2 BLOWER/MISTER JET LAVAGE FQH GUIDANT CARDIAC SURGERY CB-1000 96255092

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R