BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR FLEX 041

    MDR report key: 2181142 · Received July 8, 2011

    Report

    Report Number
    3005168196-2011-00273
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 9, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K100769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN, AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PHYSICIAN INTRODUCED THE PENUMBRA SYSTEM SEPARATOR FLEX 041 INTO THE PENUMBRA SYSTEM REPERFUSION CATHETER 041. AFTER SOME CENTIMETERS THERE WAS RESISTANCE. THE PHYSICIAN WAS NOT ABLE TO BRING THE SEPARATOR FLEX TO THE END OF THE CATHETER. THE PHYSICIAN CHANGED TO A SEPARATOR 041 AND EVERYTHING WENT FINE, AND THE PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR FLEX 041 NRY PENUMBRA INC. F17695

    Patients

    Seq Age Sex Outcome Treatment
    1