BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 1003192 · Received February 22, 2008

    Report

    Report Number
    2020394-2008-00031
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE DESPITE ATTEMPTS. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE. IT IS UNKNOWN WHETHER PATIENT OR PROCEDURAL FACTORS CONTRIBUTED TO THIS EVENT. THE CURRENT IFU (INSTRUCTION FOR USE) FOR THIS DEVICE STATES: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POTENTIAL COMPLICATIONS INCLUDED, BUT ARE NOT LIMITED TO: PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FILTER WAS TILTED AND HAD PERFORATED SOMEWHERE. DESPITE ATTEMPTS, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. AT THE TIME OF THE ORIGINAL REPORT, THERE WAS NO INDICATION THAT PATIENT INJURY HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1