BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCOL

    MDR report key: 1009025 · Received March 7, 2008

    Report

    Report Number
    2031002-2008-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 7, 2008
    Manufacturer
    HANCOCK/JAFFE LABORATORIES INC.
    Product Code
    MDQ
    PMA / PMN Number
    P020049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHOLOGY LABORATORY IS IN THE PROCESS OF EXAMINING THEIR PROCEDURES TO DETERMINE WHETHER THE PRESERVED MATERIAL CAN BE PROVIDED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A 40 CM GRAFT WAS IMPLANTED IN THE PATIENT'S FOREARM FOR USE AS HEMODIALYSIS ACCESS GRAFT. APPROXIMATELY TWO YEARS POSTOPERATIVELY, THE GRAFT APPEARED ENLARGED. THE PHYSICIAN ELECTED TO REMOVE THE GRAFT AND A NEW ACCESS WAS CREATED USING A EPTFE GRAFT. THE DEVICE HISTORY RECORD WAS REVIEWED THE DEVICE HAD BEEN MANUFACTURED FOLLOWING ALL DOCUMENTED PROCEDURES AND HAD DEMONSTRATED CONFORMANCE WITH ALL CRITERIA FOR ACCEPTANCE. THE CAUSE HAS NOT BEEN DETERMINED, HOWEVER, CANNULATION AND INCREASED PRESSURE DUE TO DOWNSTREAM STENOSIS ARE KNOWN TO BE ASSOCIATED WITH SIMILAR OCCURRENCES IN ACCESS GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCOL VASCULAR ACCESS GRAFT MDQ HANCOCK/JAFFE LABORATORIES INC. HJL016-40-N SB014063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention