BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 2063319 · Received April 11, 2011

    Report

    Report Number
    2020394-2011-00076
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 SAMPLE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF AN IVC FILTER, ONE OF THE FILTER LEGS WOULD NOT SEPARATE FROM THE PUSHER PAD OF THE DELIVERY SYSTEM. THE PHYSICIAN WAS ABLE TO FREE THE FILTER LIMB BY MANIPULATING THE DELIVERY SYSTEM; HOWEVER, IN DOING SO, THE FILTER WAS MOVED CAUDALLY AND BECAME TILTED APPROXIMATELY NINETY DEGREES, WITH THE APEX OF THE FILTER RESTING AGAINST THE WALL OF THE CAVA. AFTER THE DELIVERY SYSTEM REMOVED, A SNARE WAS ADVANCED THROUGH THE SAME FEMORAL ACCESS SITE AND THE FILTER WAS SUCCESSFULLY RETRIEVED. ANOTHER FEMORAL IVC FILTER WAS THEN IMPLANTED. NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFUD2533

    Patients

    Seq Age Sex Outcome Treatment
    1