BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1588977 · Received January 19, 2010

    Report

    Report Number
    3005168196-2010-00008
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    February 1, 2009
    Report Date
    February 9, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Removal / Correction Number
    Z-0001-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE NEURON KINKED AT THE PROXIMAL END, NEAR THE HUB OF THE CATHETER. THE PRODUCT WAS PLACED VERY DISTAL AT THE TIME OF THE KINK. THE DEVICE WAS REMOVED AND ANOTHER NEURON WAS USED. SOME KINKING WAS OBSERVED IN THE SECOND CATHETER AND THE DEVICE WAS AGAIN REMOVED AND THE CASE COMPLETED WITH ANOTHER CATHETER. NO PT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F14102

    Patients

    Seq Age Sex Outcome Treatment
    1