BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VASO VIEW HEMOPRO

    MDR report key: 1023527 · Received April 2, 2008

    Report

    Report Number
    2953148-2008-00320
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 20, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 EVAL, IT WILL BE DIFFICULT TO CONFIRM THE REPORTED PROBLEM. A LHR REVIEW WAS COMPLETED FOR THE PRODUCT AND THERE WAS NO NONCONFORMANCE ASSOCIATED WITH THE LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE WHILE USING THE DEVICE, THE PATIENT HAD SIGNIFICANT BLEEDING; ENOUGH THAT THE HARVESTER HAD A DIFFICULT TIME MANEUVERING THROUGH THE TUNNEL. THE DEVICE CUT THE BRANCH BUT DID NOT CAUTERIZE SUFFICIENTLY; THEREFORE, BLEEDING OCCURRED ON THE VEIN SIDE OF THE BRANCH. THEY WERE ABLE TO STOP THE BLEEDING AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASO VIEW HEMOPRO GEI GUIDANT CARDIAC SURGERY VH-3000 8020771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA