BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION RETRIEVABLE VENA CAVA FILTER SYSTEM

    MDR report key: 1966898 · Received December 17, 2010

    Report

    Report Number
    3003862657-2010-00002
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    August 5, 2010
    Report Date
    November 19, 2010
    Manufacturer
    REX MEDICAL, L.P.
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Product Problem
    Yes
    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: NO COMPLAINT SAMPLE WAS RETURNED TO REX MEDICAL FOR FURTHER EVALUATION. RETAIN DEVICE EVALUATION: THE REX MEDICAL ENGINEERING TEAM VISITED THEIR CONTRACT MANUFACTURER, THOMAS MEDICAL PRODUCTS, 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 FILTERS ARE LOADED IN THE CARTRIDGE PROPERLY. EACH FILTER APEX IS WHERE IT SHOULD BE LOCATED - NEARLY FLUSH WITH THE CANNULA AT THE "FEMORAL" ARROW LOCATION. ROOT CAUSE: DUE TO THE COMPLAINT SAMPLE NOT BEING RETURNED TO REX MEDICAL FOR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CONCLUSION: UPON THE CONCLUSION OF (B)(4) INVESTIGATION, IT WAS DETERMINED THAT THE IMPLEMENTATION FOR A NEW VISION SYSTEM TO INDICATE PROPER FILTER LOADING INTO THE CARTRIDGE IS ESTIMATED FOR COMPLETION BY (B)(6) 2010. THE FILING OF THIS 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 US VIA A FIELD COMPLAINT FROM OUR DISTRIBUTION PARTNER: "THE DOCTOR PLACED THE OPTION FILTER THROUGH THE FEMORAL ACCESS WITH THE CARTRIDGE PROPERLY IN PLACE. HE DEPLOYED THE FILTER AND IT WAS UPSIDE DOWN. HE REMOVED THE FILTER AND PLACED A TULIP FILTER".

    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 S31167

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention