BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1873557 · Received September 17, 2010

    Report

    Report Number
    3005168196-2010-00629
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    March 31, 2009
    Report Date
    March 31, 2009
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS NOT RETURNED FOR EVAL. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009.

    Description of Event or Problem · 1

    UPON REMOVING THE NEURON CATHETER FROM THE PACKAGING, A KINK IN THE DISTAL TIP WAS NOTICED. PRODUCT WAS PLACED BACK INTO THE PACKAGING AND A NEW NEURON WAS REMOVED FROM INVENTORY. THREE OTHER NEURONS WERE DISCOVERED TO HAVE A KINK IN THE SAME LOCATION. THERE WAS NO VISUAL DAMAGE TO THE OUTER PACKAGING (BOX). ONE CATHETER IN THE NON OPENED PACKAGING IS BEING RETURNED FOR INSPECTION. THE OTHER CATHETERS WERE REMOVED FROM PACKAGING BUT FROM HANDLING CAUSED MANY KINKS IN THE SHAFT. PLEASE FOCUS ON THE DISTAL ENDS ONLY. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00313, MDR 3005168196-2010-00630, AND MDR 3005168196-2010-00631.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA INC. F14028

    Patients

    Seq Age Sex Outcome Treatment
    1