BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINEXX 3 BILIARY STENT

    MDR report key: 1021522 · Received March 26, 2008

    Report

    Report Number
    9681442-2008-00033
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    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. THE SAMPLE WAS RETURNED FOR EVAL. THE SAFETY CLIP WAS MISSING UPON RECEIPT OF THE SAMPLE. THE HANDGRIP HAD BEEN COMPLETELY TRIGGERED AND THE SYSTEM HAD BEEN CLIPPED OUT PROXIMALLY AND PROTRUDED 135MM OUT OF THE GRIP. THE INNER CATHETER AND FILLING MATERIAL PROTRUDED 4MM FROM THE TIP OF THE OUTER SHEATH. THE STENT SHIFTED DISTAL 4MM. IT CAN BE CONFIRMED THAT THE SYSTEM WAS CLIPPED OUT OF THE PERFORMAXX GRIP PROXIMALLY, UPON RECEIPT OF THE COMPLAINT SAMPLE. IT CAN, HOWEVER, NOT BE DETERMINED WHEN AND WHERE THIS HAD OCCURRED. THE DETACHMENT OF THE PROXIMAL LUER ADAPTER (BLUE PORT) FROM THE PERFORMAXX GRIP MAY HAVE BEEN CAUSED BY THE EXERTION OF INAPPROPRIATE, EXCESSIVE FORCE DURING THE FLUSHING PROCEDURE. CONNECTING OR DISCONNECTING A SYRINGE WITH A MALE LUER LOCK MAY LEAD TO A LEVERAGE EFFECT THAT LEVERS THE BLUE WINGED ADAPTER OUT ON ONE SIDE AND PULLS IT FROM THE HOLDING GRIPPER. THIS MAY HAVE BEEN PREVENTED BY PLACING A THUMB OVER THE PROXIMAL LUER PORT WHILE ATTACHING/DETACHING THE SYRINGE DURING FLUSHING. AFTER THIS KIND OF ACCIDENTAL DETACHMENT, THE STENT MUST NOT BE RELEASED USING THE TRIGGER MECHANISM ANY MORE (AS DESCRIBED IN THE IFU). THE INFORMATION FOR USE FOR THIS DEVICE STATES: "DURING SYSTEM FLUSHING, ENSURE THAT THE DELIVERY SYSTEM DOES NOT BECOME INADVERTENTLY DETACHED FROM THE MULTIFUNCTIONAL HANDLE AT THE PROXIMAL LUER PORT. DETACHMENT CAN OCCUR DUE TO APPLICATION OF EXCESSIVE FORCE. PLACING A THUMB OVER THE PROXIMAL LUER PORT WHILE ATTACHING/DETACHING THE SYRINGE DURING FLUSHING WILL PREVENT UNINTENDED DETACHMENT". THIS APPLICATION REPRESENTS AN OFF-LABEL USE FOR THIS DEVICE. THE CURRENT INFORMATION FOR USE FOR THIS DEVICE STATES: THE LUMINEXX 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 DURING AN A/V GRAFT THROMBECTOMY WITH PTA OF THE AXILLARY/SUBCLAVIAN VEIN THE DEVICE FAILED TO DEPLOY. THERE WAS NO DIFFICULTY TRACKING TO THE INTENDED SITE AND NO RESISTANCE FELT WHEN TRYING TO DEPLOY. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMINEXX 3 BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANQC3790

    Patients

    Seq Age Sex Outcome Treatment
    1