BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XB

    MDR report key: 1579990 · Received January 14, 2010

    Report

    Report Number
    2242352-2009-00055
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 17, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IS BEING REQUESTED TO CLOSE THIS INVESTIGATION. WE WILL CONTINUE TO PURSUE ADDITIONAL INFORMATION, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A SERIOUS INJURY THAT OCCURRED DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE WHILE USING A VH-3200. DURING THE DISSECTION, CO2 WENT UP TO THE PATIENT'S BELLY AND RIGHT ATRIUM. THE CO2 EMBOLISM CAUSED THE PATIENT'S BLOOD PRESSURE TO DROP. THE HOSPITAL TURNED OFF THE CO2 AND EXTENDED THE INCISION A COUPLE OF CENTIMETERS TO CONTINUE DISSECTING AND HARVESTING THE REST OF THE VEIN. THEY DID NOT REPORT A DEVICE MALFUNCTION. THEY ALSO STATED THAT THE CO2 PRESSURE WAS SET TO 15 MMHG WHEN IT SHOULD BE 10-12 MMHG. THERE WERE NO TEARS IN THE VEIN, AND THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PROBLEMS OR PATIENT COMPLICATIONS. THE PRODUCT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XB HEMOPRO GEI MAQUET CARDIOVASCULAR, LLC VH-3200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other