BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070 ADVANCED

    MDR report key: 2625590 · Received October 27, 2009

    Report

    Report Number
    3005168196-2009-00079
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    September 28, 2009
    Report Date
    September 28, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS NOT RETURNED THEREFORE NO EVALUATION COULD BE CONDUCTED. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED AND A COPY IS ATTACHED. CONCLUSIONS: THE DEVICE WAS NOT RETURNED THEREFORE THERE IS NO FOLLOW-UP NOR CONCLUSIONS THAT CAN BE DRAWN. COMPLAINT/INCIDENT FINDINGS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 2314-01.A, (LOT #L15348). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. OD TEST PASSED. DOES NOT APPEAR RELATED TO THIS COMPLAINT. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO USE THE NEURON DELIVERY CATHETER AND WAS UNABLE TO PUT IT THROUGH A 6F SHUTTLE SHEATH. THE PHYSICIAN THEN TRIED ANOTHER UNIT OF THE SAME NEURON AND FOUND THAT IT WENT THROUGH THE 6F SHEATH SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 ADVANCED SUBCUTANEOUS CATHETER DQY PENUMBRA, INC. F15348

    Patients

    Seq Age Sex Outcome Treatment
    1