BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE FILTER SYSTEM-FEMORAL

    MDR report key: 1902143 · Received November 12, 2010

    Report

    Report Number
    2020394-2010-00330
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    August 30, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE SAMPLE EVAL WAS NOT RETURNED. THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE DEFINITIVE ROOT CAUSE IS UNK. THIS EVENT WAS REPORTED VIA VOLUNTARY MEDWATCH # (B)(4). DESPITE ATTEMPTS TO OBTAIN ADD'L INFO, IT WAS REPORTED THAT THE VOLUNTARY REPORTER DOES NOT WANT HIS/HER ID TO BE RELEASED TO THE MFR. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL; PAIN.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE FILTER SYSTEM-FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFUB1654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention