BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 4103582 · Received September 19, 2014

    Report

    Report Number
    3005168196-2014-00657
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 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 MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE : HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. AFTER SUCCESSFUL ASPIRATION USING THE 5MAX ACE REPERFUSION CATHETER, THE PATIENT DEVELOPED AN INTRACRANIAL HEMORRHAGE. THE RELATIONSHIP BETWEEN THE EVENT AND THE PENUMBRA SYSTEM IS POSSIBLE WITH THE SEVERITY BEING SEVERE. THE PATIENT'S CONDITION WAS REPORTED AS PARALYZED ON THE LEFT HAND SIDE WITH ADDITIONAL TREATMENT DUE TO BRAIN SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582509 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F43583

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other