BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 1830721 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00199
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    August 14, 2008
    Report Date
    August 26, 2008
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: VISUAL INSPECTION OF THE BOX INDICATED THAT THE BOX WAS SEVERELY DAMAGED AT THE MID SECTION. DAMAGE TO THE BOX CAUSED THE DEVICE TO KINK IN THE MIDDLE AND FLATTENED 7 CM FROM THE DISTAL TIP. CONCLUSION: THE DAMAGE COULD HAVE BEEN CAUSED BY ROUGH HANDLING OF THE BOX DURING SHIPPING AND TRANSIT. THE DHR FOR THIS MANUFACTURING LOT WAS REVIEWED. 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 1097-02 (LOT# L13036). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE LOT HAS PASSED ALL DIMENSIONAL MEASUREMENTS PER SPECIFICATION. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE BOX CONTAINING THE DEVICE WAS RECEIVED DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA INC. F13036

    Patients

    Seq Age Sex Outcome Treatment
    1