BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT VASOVIEW HEMOPRO

    MDR report key: 1013887 · Received March 14, 2008

    Report

    Report Number
    2953148-2008-00263
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. SINCE THE PRODUCT WAS NOT RETURNED TO CARDIAC SURGERY FOR EVALUATION IT WILL BE DIFFICULT TO CONFIRM THE REPORTED PROBLEM. A LHR REVIEW CANNOT BE PERFORMED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHILE USING A VH-3000, THE PT EXPERIENCED A SUDDEN HEMODYNAMIC COLLAPSE. THE SURGEON SUSPECTED A CO2 AIR EMBOLISM. THE PT WAS IMMEDIATELY PLACED ON CARDIOPULMONARY BYPASS. THE SURGEON WENT ON-PUMP TO STABILIZE THE PT AND COMPLETE THE CASE. THE HOSPITAL WAS ABLE TO CLOSE THE PATIENT'S CHEST AND AFTER THE CHEST WAS CLOSED, THE PT WAS EXTUBATED WITHOUT ANY GROSS NEUROLOGICAL ISSUES. A MEDICAL REVIEW OF THIS INCIDENT WAS COMPLETED AND INDICATED NO MALFUNCTION OF THE DEVICE WAS IDENTIFIED WHICH COULD HAVE CONTRIBUTED TO THIS PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASOVIEW HEMOPRO GEI GUIDANT CARDIAC SURGERY VH-3000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA