BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2053426 · Received March 1, 2011

    Report

    Report Number
    3005168196-2011-00072
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    March 25, 2009
    Report Date
    March 25, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE SEPARATOR WAS RETURNED IN TWO PIECES. THE BREAK OCCURRED IN THE MIDDLE OF THE PROXIMAL TAPER GRIND. CONCLUSION: THE DEVICE DAMAGE COULD HAVE BEEN CAUSED BY FRICTION BETWEEN THE SEPARATOR AND CATHETER DUE TO THE TORTUOSITY OF THE PT'S VESSELS. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING AN M1 OCCLUSION STROKE WITH THE PENUMBRA STROKE SYS. AFTER SEVERAL MANIPULATIONS WITH THE SEPARATOR 032 INSIDE THE REPERFUSION CATHETER 032, THE SEPARATOR 032 FRACTURED INTO TWO PIECES JUST DISTAL TO THE SUPPORT / FLEX ZONE TRANSITION. THE PHYSICIAN WAS VERY CAREFUL NOT TO MOVE THE TRANSITION ZONE OUTSIDE OF THE RHV DURING THE SEPARATOR MANIPULATIONS. A SECOND REPERFUSION CATHETER AND SEPARATOR WERE SELECTED RESULTING IN THE SAME SITUATION (SEPARATOR FRACTURING JUST DISTAL TO THE TRANSITION ZONE). THE SYS WAS THEN REMOVED AND A THIRD DEVICE WAS SELECTED WITHOUT DAMAGE TO THE SEPARATOR. THERE WAS NOT PT INJURY OR ADVERSE EVENTS. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2010-00047, MDR 3005168196-2011-00073 AND MDR 3005168196-2011-00074.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY PENUMBRA, INC. F14219

    Patients

    Seq Age Sex Outcome Treatment
    1