BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL

    MDR report key: 874835 · Received June 29, 2007

    Report

    Report Number
    2031002-2007-00001
    Event Type
    Malfunction
    Date Received
    June 29, 2007
    Date of Event
    June 4, 2007
    Report Date
    June 29, 2007
    Manufacturer
    HANCOCK JAFFE LABORATORIES, INC.
    Product Code
    MDQ
    PMA / PMN Number
    PO20049
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A VASCULAR GRAFT WAS IMPLANTED FOR HEMOACCESS IN THE THIGH POSITION. BETWEEN 4 AND 6 WEEKS POST IMPLANT, A SECTION OF THE GRAFT ADJOINING THE VENOUS ANASTOMOSIS DEVELOPED A PSEUDOANEURYSM APPROXIMATELY 2CM IN LENGTH. A FISTULOGRAM CONFIRMED THE DIAGNOSIS. THE GRAFT THROMBOSED UPON COMPLETION OF THE DIAGNOSTIC FISTULOGRAM AND NO ATTEMPT WAS MADE TO SALVAGE THE GRAFT WHICH WAS ABANDONED IN PLACE. THE FORMATION OF ANASTOMOTIC ANEURYSMS AND THROMBOSIS/OCCLUSION OF THE GRAFT ARE LISTED AS POSSIBLE ADVERSE EVENTS ASSOCIATED WITH THE USE OF A VASCULAR ACCESS GRAFT IN THE INSTRUCTIONS FOR USE. THE DEVICE HISTORY RECORD FOR THE DEVICE WAS REVIEWED. THE DEVICE WAS MANUFACTURED AND INSPECTED IN ACCORDANCE WITH ALL STANDARD MANUFACTURING PROCESSES AND MET ALL CRITERIA FOR ACCEPTANCE. A CAUSE FOR THE EVENT WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCOL VASCULAR ACCESS GRAFT MDQ HANCOCK JAFFE LABORATORIES, INC. HJL016-40-N SB014066

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR