BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1397487 · Received June 2, 2009

    Report

    Report Number
    3006262933-2009-00449
    Event Type
    Injury
    Date Received
    June 2, 2009
    Date of Event
    April 8, 2009
    Report Date
    May 7, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GCJ
    PMA / PMN Number
    K030512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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.

    Description of Event or Problem · 1

    THE HOSPITAL NOTIFIED MAQUET FIELD CLINICAL REPRESENTATIVE (FCR) THAT BLISTERS WERE OBSERVED MANY DAYS POST-OP IN OCCURRED CASE. IN 2009, FCR STATED, "THE INCISION NEAR THE KNEE CONSISTENT WITH AN INCISION MADE FOR EVH. THERE ARE ALSO 2-3 ADDITIONAL SKIP INCISIONS ON EACH LEG, APPROXIMATELY 2-4 CM, INDICATING A BRIDGING TYPE PROCEDURE IN ADDITION TO EVH. THE HEAD CARDIAC NURSE STATES THAT THE FACILITY HAS BEEN DOING EVH AS LONG AS SHE CAN RECALL, AND HAS BEEN DOING IT THE SAME WAY. THIS IS THE FIRST TIME THEY HAVE SEEN ANYTHING LIKE THIS. THE HEAD CARDIAC NURSE WAS NOT SURE IF THE PATIENT MIGHT HAVE BEEN BURNED, BUT COULD NOT FIGURE OUT HOW THAT COULD HAVE HAPPEN. THE PATIENT'S FEET ARE WRAPPED LOOSELY IN BAGS, AND IOBAND IS USED TO COVER BOTH LEGS. AFTER THE CASE, THE LEG WAS WRAPPED WITH AN ACE FROM THE ANKLE UP, BUT NOT THE FOOT. FROM THE INCISIONS SEEN IN THE PHOTOGRAPHY, IT APPEARS AS THOUGH THE VEIN WAS HARVESTED FROM THE GROIN TO THE MID-CALF. THERE ARE APPROXIMATELY 3 SKIP INCISIONS. FOLLOWING VEIN HARVEST, THERE WERE 2 JP DRAINS PLACED IN THE LEFT LEG. ON POST-OP DAY 20, THE PATIENT WAS FOUND TO HAVE MULTIPLE BLISTERS, FROM APPROXIMATELY 1CM TO 3 CM ON THE MEDIAL SIDE OF THE LEFT LEG, THE EVH LEG, ALONG WITH DEPENDENT POOLING OF BLOOD ON THAT SIDE. THERE WERE ALSO A COUPLE OF SMALL BLISTERS ON THE DORSUM OF RIGHT FOOT. THE PATIENT IS UNDER THE CARE OF WOUND CARE NURSE AND THE BLISTERS ARE IMPROVING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ MAQUET CARDIOVASCULAR VH-3200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention