BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM

    MDR report key: 3131536 · Received May 15, 2013

    Report

    Report Number
    2020394-2013-00151
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE INVESTIGATION LOT NUMBER IS UNKNOWN. THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR FILTER LIMB PERFORATION AND THE REPORTED REMOVAL DIFFICULTIES. UNABLE TO DETERMINE THE ROOT CAUSE BASED UPON THE AVAILABLE INFORMATION. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. NOTE: IT IS POSSIBLE THAT COMPLICATIONS SUCH AS THOSE DESCRIBED IN THE "WARNINGS", "PRECAUTIONS," OR "POTENTIAL COMPLICATIONS" SECTIONS OF THESE INSTRUCTIONS FOR USE MAY AFFECT THE RECOVERABILITY OF THE DEVICE AND RESULT IN THE CLINICIAN'S DECISION TO HAVE THE DEVICE REMAIN PERMANENTLY IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED VENA CAVA FILTER RETRIEVAL, FLUOROSCOPY DEMONSTRATED A FILTER LIMB PERFORATION OF THE IVC. THE FILTER WAS UNABLE TO BE RETRIEVED SUCCESSFULLY; THEREFORE, THE FILTER REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216272 ECLIPSE FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1