BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINEX 3 BILIARY STENT

    MDR report key: 1001295 · Received February 19, 2008

    Report

    Report Number
    9681442-2008-00017
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    ANGIOMED GMBH & CO., MEDIZINTECHNIK
    Product Code
    FGE
    PMA / PMN Number
    K033497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT, AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. NO SAMPLE WAS RETURNED AND A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN. THIS APPLICATION REPRESENTS AN OFF-LABEL USE FOR THIS DEVICE. THE CURRENT INFORMATION FOR USE FOR THIS DEVICE STATES: THE LUMINEX 3 BILIARY STENT IS INDICATED FOR USE IN THE TREATMENT OF BILIARY STRICTURES RESULTING FROM MALIGNANT NEOPLASMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BACK PIECE POPPED OUT OF THE HANDGRIP AND THE DOCTOR COULD NOT DEPLOY THE STENT. THE PROCEDURE WAS STENTING THE FEMORAL ARTERY. AN 8F SHEATH AND A 0.035 GUIDE WIRE WERE USED FOR THE PROCEDURE. THE DOCTOR HAD NO DIFFICULTY ADVANCING TO THE INTENDED AND HE THOUGHT HE DEPLOYED THE STENT. WHEN THE SYSTEM WAS REMOVED, THE STENT WAS STILL IN THE DELIVERY SYSTEM AND IT WAS NOTED THAT THE BACK PIECE HAD POPPED OUT OF THE HANDGRIP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMINEX 3 BILIARY STENT FGE ANGIOMED GMBH & CO., MEDIZINTECHNIK ANRC0674

    Patients

    Seq Age Sex Outcome Treatment
    1