BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, FEMORAL

    MDR report key: 1032286 · Received April 21, 2008

    Report

    Report Number
    2020394-2008-00096
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE LOT MET ALL RELEASE CRITERIA. UPON INSPECTION OF THE RETURNED SAMPLE, THE DILATOR WAS REMOVED FROM THE INTRODUCER SHEATH. THE DILATOR MOVED FREELY THROUGH THE INTRODUCER SHEATH AND WAS INTACT AND UNDAMAGED. THE INTRODUCER SHEATH WAS MISSING THE DISTAL GOLD BAND AND THE TIP APPEARED SOMEWHAT FLARED. THERE WAS AN IMPRESSION ON THE INTRODUCER SHEATH WHERE THE GOLD BAND HAD BEEN SWAGED. THE BAND WAS RETURNED ON THE GUIDE WIRE (UNKNOWN MANUFACTURER). ALL MEASUREMENTS TAKEN WERE WITHIN SPECIFICATION. THE RESULT OF THE INVESTIGATION CONFIRMED FOR THE MARKER BAND DETACHED FROM THE INTRODUCER SHEATH, ROOT CAUSE UNKNOWN. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT A VENA CAVA FILTER VIA THE FEMORAL, THE DOCTOR HAD A DIFFICULT TIME ADVANCING THE SYSTEM. THE SYSTEM WAS REMOVED FROM THE PATIENT, AND IT WAS NOTICED THAT THE MARKER BAND HAD COME OFF OF THE CATHETER, BUT WAS STILL ON THE GUIDE WIRE. THE GUIDEWIRE WAS REMOVED WITH THE MARKER BAND AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER VENA CAVA FILTER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM, FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFR14773

    Patients

    Seq Age Sex Outcome Treatment
    1