BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL

    MDR report key: 1056017 · Received June 3, 2008

    Report

    Report Number
    2031002-2008-00003
    Event Type
    Malfunction
    Date Received
    June 3, 2008
    Date of Event
    April 30, 2008
    Report Date
    June 3, 2008
    Manufacturer
    HANCOCK/JAFFE LABORATORIES, INC.
    Product Code
    MDQ
    PMA / PMN Number
    PO20049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE TIME OF THIS REPORT, THE IMPLANT DATE AND DEVICE SERIAL NUMBER AND/OR MODEL NUMBER HAVE NOT BEEN LOCATED. AS A CONSEQUENCE THERE HAS BEEN INVESTIGATION INTO THE DEVICE ITSELF AT THIS TIME.

    Description of Event or Problem · 1

    A GRAFT WAS IMPLANTED IN THE PT'S FOREARM FOR USE AS A SITE FOR HEMODIALYSIS ACCESS. IT WAS REPORTED THAT THE DIAMETER OF THE GRAFT APPEARED ENLARGED AND THE DR ELECTED TO LIGATE THE GRAFT. IT WAS ALSO REPORTED THAT THERE WAS VISUAL EVIDENCE OF "BAD NEEDLE STICKS" INDICATING CANNULATION TRAUMA. A NEW SYNTHETIC GRAFT WAS PLACED FOR THE PT'S VASCULAR ACCESS. A SECTION OF EXPLANTED GRAFT WAS RETURNED AND ANALYSIS IS IN-PROCESS. THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED; HOWEVER, CANNULATION AND INCREASED PRESSURE DUE TO DOWNSTREAM STENOSIS WAS KNOWN TO BE ASSOCIATED WITH SIMILAR OCCURRENCES IN ACCESS GRAFTS AND THESE EVENTS ARE LISTED IN THE LABELING PROVIDED WITH THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention