BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2923396 · Received January 22, 2013

    Report

    Report Number
    3005168196-2013-00034
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 14, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THE CATHETER IS KINKED 1 CM FROM THE STRAIN RELIEF. THE CATHETER ALSO HAS OTHER KINKS AND PINCHES LONG THE ENTIRE SHAFT. A 0.070" MANDREL COULD NOT BE INTRODUCED THROUGH THE HUB OF THE CATHETER. THE CATHETER IS NON-FUNCTIONAL. THE KINK NOTED IN THE COMPLAINT IS CONFIRMED. THE CATHETER DID HAVE A KINK IN THE PROXIMAL END APPROXIMATELY (1CM) FROM THE STRAIN RELIEF. THIS WAS LIKELY DUE TO OPERATOR TECHNIQUE. IF THE CATHETER IS BENT AT A SEVERE ANGLE DURING MANIPULATION IN THE PATIENT WHEN BEING HELD AT THE PROXIMAL HUB END, THE PROXIMAL END OF THE CATHETER MAY KINK AT OR NEAR THE STRAIN RELIEF. THE CATHETER ALSO HAD OTHER KINKS AND PINCHES ALONG THE ENTIRE SHAFT OF THE CATHETER WHICH LIKELY OCCURRED AS A RESULT OF POST-PROCEDURAL HANDLING AND PACKAGING FOR RETURN. 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

    THE PHYSICIAN WAS DOING A STENT ASSISTED COILING CASE OF A BASILAR ARTERY ANEURYSM. HE ADVANCED THE NEURON 070 UP THRU THE RIGHT VERTEBRAL ARTERY TO THE LEVEL OF APPROX C2. HE PUT A XT CATHETER INSIDE OF THE NEURON 070 AND ADVANCED THAT TO THE RT PCA. THE CATHETER KINKED AT THE PROXIMAL END. THE PHYSICIAN WAS ABLE TO FINISH THE CASE, AND WAS ABLE TO FLUSH AND INJECT. HIS MAIN CONCERN WAS THAT THE FLUSH THRU THE NEURON 070 WASN'T OPTIMAL ,AND COULD HAVE LED TO CLOT FORMATION INSIDE OF THE CATHETER. THE CASE WAS SUCCESSFUL AND THERE WAS NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29877 NEURON DELIVERY CATHETER 070 DQY DQY PENUMBRA, INC. F25803

    Patients

    Seq Age Sex Outcome Treatment
    1