BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2624164 · Received September 30, 2009

    Report

    Report Number
    3005168196-2009-00066
    Event Type
    Other
    Date Received
    September 30, 2009
    Date of Event
    October 2, 2007
    Report Date
    September 28, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: AS PER FDA FEEDBACK OF 28 AUGUST 2009, THESE SORTS OF EVENTS MUST BE REPORTED. THERE WAS NO DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    REMEDIATION-PHYSICIAN EVALUATION: DURING THE TREATMENT OF A LARGE MCA ANEURYSM, A MINOR VASOSPASM WAS NOTED WHILE ADVANCING THE NEURON CATHETER TO THE HIGH PETROUS. THE SPASMING WAS RESOLVED BY BACKING OUT THE NEURON FROM ITS RELATIVELY HIGH POSITION. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1