BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2151596 · Received June 24, 2011

    Report

    Report Number
    3005168196-2011-00257
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN INTRODUCED THE PENUMBRA SYSTEM SEPARATOR 032 INTO THE RHV AND IT KINKED AND FRACTURED. THE DISTAL SEGMENT WAS REMOVED FROM THE RHV. A SECOND DEVICE WAS USED AND THE SAME THING HAPPENED TO THE SECOND SEPARATOR. A THIRD SEPARATOR WAS USED AND THE PROCEDURE WAS COMPLETED. THE PT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00258.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY PENUMBRA INC. F18169

    Patients

    Seq Age Sex Outcome Treatment
    1