BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM-FEMORAL

    MDR report key: 1903136 · Received November 11, 2010

    Report

    Report Number
    2020394-2010-00328
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 MFG PROCESS AND THE QC TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE FILTER REMAINS IMPLANTED IN THE PT. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE F/U, IMAGING DEMONSTRATED THAT TWO IVC FILTER LEGS WERE OUTSIDE THE CONTRAST COLUMN OF THE IVC. HOWEVER, THERE WAS NO EXTRAVASATION. THE PT IS ASYMPTOMATIC AND RETRIEVAL ATTEMPTS HAVE NOT YET BEEN PERFORMED. FURTHER INFO IS PENDING. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE FILTER SYSTEM-FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFUD2539

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR