BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMON NITINOL FILTER - JUGULAR

    MDR report key: 2142551 · Received June 20, 2011

    Report

    Report Number
    2020394-2011-00135
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K970099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE FILTER REMAINS IMPLANTED. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IVC FILTER FAILED TO COMPLETELY OPEN UPON DEPLOYMENT. REPORTEDLY, THE FILTER LEGS WERE NOT CROSSED OR TWISTED. AN ATTEMPT TO RETRIEVE THE PERMANENT FILTER WAS MADE USING A SNARE AND AN 11F INTRODUCER SHEATH THROUGH THE SAME JUGULAR ACCESS SITE. HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL AND THE FILTER REMAINS IMPLANTED. ANOTHER MANUFACTURER'S IVC FILTER WAS THEN IMPLANTED THROUGH THE SAME ACCESS SITE IN A SUPRARENAL LOCATION WITHOUT FURTHER INCIDENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMON NITINOL FILTER - JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFVA3270

    Patients

    Seq Age Sex Outcome Treatment
    1