BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1915364 · Received November 3, 2010

    Report

    Report Number
    3005168196-2010-00674
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 5, 2010
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVAL AND A F/U MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    WHILE FLUSHING THE NEURON WHEN PREPARING FOR A CASE, THE TECHNICIAN NOTICED THAT THE TIP OF THE CATHETER WAS KINKED. THE TECHNICIAN REPLACED THE CATHETER AND THERE WAS NO EFFECT ON THE PROCEDURE OR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA INC. F17089

    Patients

    Seq Age Sex Outcome Treatment
    1