BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1993808 · Received January 13, 2011

    Report

    Report Number
    3005168196-2011-00020
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    February 2, 2010
    Report Date
    February 4, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: LOT# F15318: THE TIP WAS FLATTENED FOR THE FIRST 0.7CM FROM THE DISTAL TIP. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY OR DESIGN CONCERNS. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009.

    Description of Event or Problem · 1

    THE PHYSICIAN FOUND THAT THE TIP OF THE NEURON CATHETER WAS CRIMPED AND UNUSABLE UPON OPENING THE PACKAGING. THE PHYSICIAN THEN OPENED ANOTHER NEURON AND FOUND THAT TO BE CRIMPED AS WELL. A THIRD UNIT WAS THEN OPENED AND USED SUCCESSFULLY. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-000121.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15318

    Patients

    Seq Age Sex Outcome Treatment
    1