BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY G2 FILTER SYSTEM - JUGULAR

    MDR report key: 2072548 · Received April 22, 2011

    Report

    Report Number
    2020394-2011-00095
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K073090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS 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 INVESTIGATION IS CURRENTLY UNDERWAY. NOTE: THIS REPORT IS THE SAME PATIENT AND SAME PRODUCT AS MANUFACTURER REPORT NUMBER 2020394-2011-00094.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON DEPLOYMENT, THE ARMS OF THE IVC FILTER WERE TWISTED. THE FILTER WAS RETRIEVED DURING THE SAME PROCEDURE WITHOUT FURTHER INCIDENT. A SECOND IVC FILTER WAS PLACED; HOWEVER, THE ARMS OF THE SECOND IVC FILTER WERE ALSO REPORTEDLY TWISTED. THIS FILTER REMAINS IMPLANTED. IT WAS SUBSEQUENTLY REPORTED THAT THE SECOND FILTER WAS RETRIEVED SEVEN DAYS LATER, AS IT WAS NO LONGER NEEDED. THE FILTER ARMS WERE COMPLETELY OPEN AT THAT TIME. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVERY G2 FILTER SYSTEM - JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFUD3927

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR