BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 2142156 · Received May 26, 2011

    Report

    Report Number
    3005168196-2011-00227
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ROUNDING THE NEURON DELIVERY CATHETER 053 FOR PREPARATION IN A SALINE BATH ON THE BACK TABLE. AT THIS POINT, HE REALIZED THE DISTAL PART OF THE NEURON WAS BROKEN AND ONLY CONNECTED BY A THIN FILAMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 DQY PENUMBRA INC. F18071

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR