BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2923398 · Received January 22, 2013

    Report

    Report Number
    3005168196-2013-00031
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 21, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE VISIBLE KINKS ON THE CATHETER IN THE PROXIMAL SHAFT NEAR THE STAINLESS STEEL STRAIN RELIEF APPROXIMATELY 6.5 CM AND 8.1 CM DISTAL OF THE HUB. A 0.070 MANDREL WAS INTRODUCED INTO THE HUB AND WAS NOT ABLE TO ADVANCE DISTALLY. THE MANDREL WAS NOT ABLE TO ADVANCE DISTALLY BECAUSE OF THE KINK IN THE CATHETER. THE CATHETER IS NOT FUNCTIONAL. CONCLUSION: THE ISSUE NOTED IN THE COMPLAINT WAS CONFIRMED. THE DAMAGE SEEN DURING THE EVALUATION IS TYPICAL OF DAMAGE CAUSED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IF THE CATHETER HUB IS PULLED FROM THE SHIPPING TUBE AT AN ANGLE, THESE KINKS IN THE PROXIMAL SHAFT OFTEN OCCUR. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    CATHETER WAS FOUND KINKED UPON OPENING PACKAGE, WAS NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30728 NEURON DELIVERY CATHETER 070 DQY DQY PENUMBRA, INC. F30096

    Patients

    Seq Age Sex Outcome Treatment
    1