BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENUMBRA SYS CATHETER 026/NEURON CATHETER 053

    MDR report key: 1661799 · Received April 16, 2010

    Report

    Report Number
    3005168196-2010-00472
    Event Type
    Other
    Date Received
    April 16, 2010
    Date of Event
    September 22, 2009
    Report Date
    March 12, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN COULD NOT CONFIRM THE RELATIONSHIP OF THE EVENT TO THE DEVICE.

    Description of Event or Problem · 1

    DURING TREATMENT OF A PT WITH THE PENUMBRA SYSTEM AND NEURON GUIDE CATHETER, A CONTROL ANGIOGRAM SHOWED THERE WAS VASOSPASM OF THE DISTAL ANGULAR BRANCH OF THE RIGHT ICA. THEREFORE, 5MG NICARDIPINE WAS PLACED INTO THE RIGHT ICA. CONTROL ANGIOGRAPHY SHOWED IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYS CATHETER 026/NEURON CATHETER 053 PERCUTANEOUS CATHETER NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention