BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION ELITE IVC FILTER

    MDR report key: 6192187 · Received December 20, 2016

    Report

    Report Number
    1625425-2016-00097
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 21, 2016
    Report Date
    December 20, 2016
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DTK
    PMA / PMN Number
    K133243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A GUIDEWIRE, COOK BRAND 4F CATHETER, AND PIECES OF A GUIDEWIRE WERE RETURNED AND EVALUATED. THE PROXIMAL END OF THE GUIDEWIRE WAS INTACT, BUT THE DISTAL END HAD UNRAVELED. THE WIRE WAS FOUND IN THREE PIECES: ONE INSIDE THE 4F CATHETER, ONE IN A SEPARATE BAG (UNRAVELED) AND THE THIRD SECTION THROUGH THE FILTER. THIS DAMAGE COULD BE A RESULT OF HANDLING IN THE USER ENVIRONMENT OR A RESULT OF A MANUFACTURING ISSUE (HOWEVER THE MANUFACTURER OF THE GUIDEWIRE IS UNKNOWN). THE PORTION OF THE WIRE IN THE FILTER, WHICH HAD UNRAVELED, WAS FREE TO MOVE WITHIN THE LUMEN OF THE FILTER. THE RETURNED FILTER APPEARED CORRECT WITH A REGULAR SHAPE AND NO BURRS. THE DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION. THE GUIDEWIRE BREAKAGE COULD NOT BE CONFIRMED TO BE RELATED TO THE FILTER OR DELIVERY SYSTEM.

    Description of Event or Problem · 1

    THE DOCTOR WAS PLACING A FILTER USING THE OVER THE WIRE APPROACH THROUGH THE FEM. AFTER DEPLOYMENT OF THE FILTER, THE BENTSON GUIDE WIRE WAS CAUGHT ON THE FILTER HUB. HE COULD NOT PUSH OR PULL THE WIRE. THEY OPENED UP FROM THE JUG AND MANAGED TO REMOVE THE FILTER AND WIRE THAT WAS SNAGGED. ANOTHER FILTER WAS PLACED JUST AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840633 OPTION ELITE IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER DTK ARGON MEDICAL DEVICES INC. Q991220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention