BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE VENA CAVA FILTER - JUGULAR

    MDR report key: 1800740 · Received August 4, 2010

    Report

    Report Number
    2020394-2010-00240
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS NOTHING FOUND IN THE RECORDS TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE FILTER HAS BEEN RETURNED FOR EVAL AND THE INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT INVOLVES TWO DEVICES USED IN THE PT; THEREFORE, THIS EVENT IS ASSOCIATED WITH THE EVENT REPORTED UNDER MANUFACTURER REPORT NO 2020394-2010-00239.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON FILTER DEPLOYMENT, TWO FILTER LEGS WERE CROSSED. AFTER DEPLOYMENT, THE PHYSICIAN WAS UNABLE TO OPEN THE CROSSED FILTER LEGS WITH A CATHETER. THE PHYSICIAN RETRIEVED THE FILTER AND DEPLOYED ANOTHER VENA CAVA FILTER. UPON DEPLOYMENT OF THE SECOND FILTER, IT APPEARED THAT AGAIN, TWO OF THE FILTER'S LEGS WERE CROSSED. THE PHYSICIAN ATTEMPTED TO UNCROSS THEM BUT WAS ALSO UNSUCCESSFUL. AGAIN, THE PHYSICIAN RETRIEVED THE FILTER AND THIS TIME, THE PHYSICIAN DEPLOYED A COMPETITOR'S FILTER. UPON DEPLOYMENT, IT WAS IDENTIFIED THAT THE COMPETITOR'S FILTER LIMBS WERE ALSO CROSSED. THIS FILTER WAS LEFT IMPLANTED. THE PHYSICIAN SUSPECTS THERE MAY BE A PT ABNORMALITY, BUT WAS UNABLE TO DETERMINE THE PROBLEM. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE VENA CAVA FILTER - JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFUC2253

    Patients

    Seq Age Sex Outcome Treatment
    1