BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2013709 · Received February 4, 2011

    Report

    Report Number
    3005168196-2011-00041
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    April 6, 2009
    Report Date
    April 6, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Removal / Correction Number
    Z-001-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE KINKS IN THE PROXIMAL END ARE SEVERE ALTHOUGH IT IS UNCLEAR IF THESE OCCURRED DURING THE INCIDENT OR DURING RETURN SHIPMENT FOR THE EVALUATION. THE TWISTING/COMPRESSION DAMAGE IS CONSISTENT WITH THE MALFUNCTION DESCRIBED IN THE INCIDENT.

    Description of Event or Problem · 1

    TWO NEURON 070 KINKED DURING AN ACOM ANEURYSM CASE. UPON THE WITHDRAWAL OF THE SECOND NEURON, THE CATHETER FRACTURED IN HALF. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1