BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1760682 · Received July 13, 2010

    Report

    Report Number
    3005168196-2010-00527
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL WAS UNSURE WHICH VERSIONS OF THE NEURON 070 WAS INVOLVED IN THE COMPLAINT. THE DEVICE WAS NOT RETURNED. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    UPON OPENING THE CATHETER PRIOR TO A PROCEDURE, THE NEURON 070 WAS NOTED TO HAVE A FLATTENED PORTION JUST PROXIMAL TO THE DISTAL MARKER BAND. THE UNIT WAS DISPOSED OF AND ANOTHER OPENED TO COMPLETE THE TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1