BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 4843205 · Received June 14, 2015

    Report

    Report Number
    3005168196-2015-00590
    Event Type
    Injury
    Date Received
    June 14, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 14, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K133317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: K133317.

    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.THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. HOSPITAL DISCARDED DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER. THE PHYSICIAN SUCCESSFULLY ASPIRATED SOME THROMBUS USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER AND ANOTHER MANUFACTURER'S DEVICE. THE PHYSICIAN THEN ATTEMPTED TO RECANALIZE THE M2 AND M3 SEGMENTS WITH THE 3MAX CATHETER. DURING ASPIRATION, A VESSEL DISSECTION OCCURRED. THE PHYSICIAN SUCCESSFULLY STOPPED THE BLEEDING WITH ANOTHER MANUFACTURER'S BALLOON DEVICE. THE PATIENT IS DOING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387085 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F63005

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention