BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER

    MDR report key: 3873077 · Received June 13, 2014

    Report

    Report Number
    3005168196-2014-00379
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    September 22, 2013
    Report Date
    May 16, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY USING THE PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM MILD IN SEVERITY. FOLLOWING THE PROCEDURE, THE PATIENT BEGAN EXPERIENCING INTERMITTENT HEADACHES WHICH WERE RESOLVED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350111 PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other