BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER SYSTEM

    MDR report key: 1966897 · Received December 17, 2010

    Report

    Report Number
    3003862657-2010-00003
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 19, 2010
    Manufacturer
    REX MEDICAL, L.P.
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED TO OBTAIN ANY AND ALL INFO PERTAINING TO THE OPTION FILTER PLACEMENT. COMPLAINT SAMPLE EVALUATION: THE COMPLAINT SAMPLE THAT WAS RETURNED TO REX MEDICAL FOUND DEFORMATION MARKS ON THE CARTRIDGE "KEY" FEATURES THAT INDICATE THE FILTER LOADING LOCATOR PIN WAS IMPROPERLY FORCED INTO THE CARTRIDGE RESULTING IN THE FILTER BEING LOADED THE WRONG WAY DUE TO IMPROPER FILTER CARTRIDGE ORIENTATION. RETAIN DEVICE EVALUATION: THE REX MEDICAL ENGINEERING TEAM VISITED THEIR CONTRACT MANUFACTURER, (B)(4), TO EXAMINE THE DEVICE RETAINS FROM THIS MANUFACTURED LOT NUMBER. THERE WERE FIVE RETAINS KEPT FROM THIS LOT OF FILTER/CARTRIDGE ASSEMBLIES. VISUAL INSPECTION UNDER MAGNIFICATION SHOWS THAT ALL RETAINED FILTERS ARE LOADED INTO THE CARTRIDGES PROPERLY. EACH FILTER APEX IS WHERE IT SHOULD BE LOCATED - NEARLY FLUSH WITH THE CANNULA AT THE "FEMORAL" ARROW LOCATION. ROOT CAUSE: THE PRESUMPTIVE ROOT CAUSE WAS REVEALED TO BE THAT DURING THE FILTER LOADING PROCESS, THE CARTRIDGE WAS FORCED INTO THE FIXTURE INCORRECTLY, THEREFORE, CAUSING THE FILTER TO BE LOADED IMPROPERLY / BACKWARDS. CONCLUSION: UPON THE CONCLUSION OF (B)(4) INVESTIGATION, IT WAS DETERMINED THAT THE IMPLEMENTATION FOR (B)(4). THE FILING OF THE MDR REPORT WAS COMPLETED ONCE THE FINAL INVESTIGATIONS AND CONCLUSIONS HAD BEEN DETERMINED AND CLOSED OUT.

    Description of Event or Problem · 1

    AS REPORTED TO REX MEDICAL VIA A FIELD COMPLAINT ON (B)(6) 2010 FROM OUR DISTRIBUTION PARTNER: "SHEATH AND DILATOR WERE PLACED FOR A FEMORAL DEPLOYMENT. THE DILATOR WAS REMOVED AND THE CARTRIDGE WAS SNAPPED INTO SHEATH WITH THE WORD FEMORAL AND GREEN ARROW FACING INTO THE SHEATH. THE FILTER WAS ADVANCED TO THE MARKER. (B)(6) PINNED THE DILATOR AND PULLED BACK ON THE SHEATH. THE FILTER WAS DELIVERED UPSIDE DOWN WITH THE APEX FACING CAUDALLY. I WAS THERE TO OBSERVE, CONFIRM AND DOUBLE CHECK DIRECTION OF THE FILTER CARTRIDGE. THE FILTER WAS LOADED INTO THE CARTRIDGE UPSIDE DOWN. I HAVE THE FILTER, SHEATH AND CARTRIDGE IS STILL ATTACHED AND HAS NOT BEEN REMOVED. A 9FR CHECK FLOW SHEATH AND ENSNARE WERE USED TO RETRIEVE THE FILTER. A NEW FILTER AND KIT WERE USED, FOR A SUCCESSFUL IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTION RETRIEVABLE VENA CAVA FILTER SYSTEM INFERIOR VENA CAVA FILTER DTK REX MEDICAL, L.P. 352506070 S31282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention