BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2021345 · Received February 8, 2011

    Report

    Report Number
    3005168196-2011-00024
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN AND A F/U MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE PT WAS ENROLLED INTO THE PULSE TRIAL AND TREATED FROM AN MI MCA OCCLUSION WITH CLOT EXTENDING INTO THE SUPERIOR AND INFERIOR BRANCHES OF THE M2 SEGMENT. THE PULSE DEVICE WAS SUCCESSFUL IN REVASCULARIZING THE M1 AND M2 INFERIOR BRACH, HOWEVER OCCLUSION REMAINED IN THE M2 SUPERIOR BRANCH. AN ATTEMPT WAS MADE TO REVASCULARIZE THE SUPERIOR M2 USING AN PENUMBRA SYSTEM REPERFUSION CATHETER AND SEPARATOR 032. HOWEVER, THE PHYSICIAN WAS NOT ABLE TO DEPLOY THE SEPARATOR BECAUSE IT WAS SOMEHOW STUCK IN THE DISTAL PART OF THE CATHETER. THE SEPARATOR "TORE" WHEN THE PHYSICIAN TRIED TO REMOVE IT. THE CATHETER AND SEPARATOR WERE PULLED OUT OF THE PT AND THE ASPIRATION ATTEMPT WAS TERMINATED. THE PROCEDURE WAS LATER TERMINATED FOLLOWING ADMINISTRATION OF UROKINASE INTO THE SUPERIOR M2 MCA. THE DEVICE MALFUNCTION WAS NOT ASSOCIATED WITH AN ADVERSE EVENT. THE PT IS STILL RECOVERING FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY PENUMBRA, INC. F17503

    Patients

    Seq Age Sex Outcome Treatment
    1