BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER

    MDR report key: 3869514 · Received April 30, 2014

    Report

    Report Number
    3003862657-2014-00003
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    December 13, 2013
    Report Date
    March 7, 2014
    Manufacturer
    REX MEDICAL, L.P.
    Product Code
    DTK
    PMA / PMN Number
    K081410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FOLLOWUP: PRODUCT COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION; NO CASE IMAGES, VIDEOS, ETC. WERE PROVIDED FOR REVIEW. COMPLAINT SAMPLE EVALUATION: COMPLAINT SAMPLE WAS RETURNED TO REX FOR REVIEW. RETAIN DEVICE EVALUATION: NO DEVICE RETAIN EVALUATION PERFORMED FOR THIS LOT NO. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS REPORTED PRODUCT COMPLAINT COULD NOT BE DETERMINED. CONCLUSION: THE DEVICE IN QUESTION WAS RETURNED FOR EVALUATION ON (B)(4) 2014. THE DELIVERY SHEATH, PUSHER WIRE AND FILTER CARTRIDGE WERE RETURNED FOR EVALUATION. ALL RETURNED ITEMS WERE WITHIN SPEC; NO ABNORMALITIES OR DEFECTS WERE NOTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED TO CHECK FOR ABNORMALITIES DURING THE MANUFACTURE OF THE LOT NUMBER IN QUESTION. NONE WERE NOTED. A RETAIN DEVICE EVALUATION WAS NOT PERFORMED ON DEVICES FROM THE SAME LOT AS THE COMPLAINT PRODUCT. A REVIEW OF THE TREND ANALYSIS FOUND ON PREVIOUS INSTANCES OF COMPLAINTS OF A SIMILAR NATURE. A DEFINITIVE ROOT CAUSE FOR THIS REPORTED PRODUCT COMPLAINT WAS NOT ABLE TO BE DETERMINED. THIS IS CONSIDERED AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    PER THE FIELD COMPLAINT FORM: IVC FILTER DID NOT DEPLOY PROPERLY. UPON FURTHER MANIPULATION, THE FILTER DEPLOYED FULLY. THE DELIVERY SYSTEM WILL BE SENT BACK TO MANUFACTURER FOR FURTHER EVALUATION. DEVICE USAGE PROBLEM (DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258683 OPTION ELITE RETRIEVABLE VENA CAVA FILTER INFERIOR VENA CAVA FILTER DTK REX MEDICAL, L.P. 352506070E Q527372

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other