BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER

    MDR report key: 1963518 · Received December 20, 2010

    Report

    Report Number
    3005168196-2010-00706
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 29, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A NEURON WAS PULLED FROM THE PACKAGING AND THERE WAS A CRIMP ON THE DISTAL TIP. THE PRODUCT WAS NOT USED TO TREAT THE PT. A NEW NEURON WAS USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F17691

    Patients

    Seq Age Sex Outcome Treatment
    1