BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIXENE 4-7MMX35CM GWT-GW, W/DBL GDS

    MDR report key: 2972334 · Received February 15, 2013

    Report

    Report Number
    1219977-2013-00006
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K071923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY AWAITING THE RETURN OF THE DEVICE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE STERILIZATION RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND NO DEVIATIONS WERE FOUND. PRODUCT COMPLAINTS WERE REVIEWED AND THERE HAVE BEEN NO OTHER COMPLAINTS TO DATE PERTAINING TO THE DESCRIPTION OF EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    UPPER ARM STRAIGHT CONFIGURATION PARALLEL TO OLD GRAFT WHICH HAD FAILED AND CONTAINED MULTIPLE PSEUDO ANEURYSMS. USED 7MM TIP TO TUNNEL WITH KELLYWICK TUNNELER. PULLED GRAFT IN AND ATTEMPTED TO REMOVE PLASTIC SHEATH BUT PLASTIC KEPT TEARING . REMOVED GRAFT TO ENSURE COMPLETE REMOVAL OF PLASTIC. TRIED TO REINSERT AFTER PLASTIC WAS REMOVED, COULDN'T REINSERT. HAD TO USE A DIFFERENT GRAFT WHICH CAUSED SUBSTANTIAL DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69591 FLIXENE 4-7MMX35CM GWT-GW, W/DBL GDS DSY ATRIUM MEDICAL CORP. 25129 AK06613

    Patients

    Seq Age Sex Outcome Treatment
    1