BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1588155 · Received January 20, 2010

    Report

    Report Number
    3005168196-2010-00093
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    September 14, 2009
    Report Date
    January 4, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED AND A COPY IS ATTACHED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART# 2314-02 (LOT# L15522). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION. (B)(4). THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A COIL EMBOLISM FOR AN ANEURYSM. AFTER THE GUIDING CATHETER WAS IN, THE HUB CRACKED, AND IT HAD TO BE REPLACED WITH ANOTHER ONE. THE PT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15522

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR