BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 041

    MDR report key: 1963563 · Received December 20, 2010

    Report

    Report Number
    3005168196-2010-00709
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    December 1, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW UP 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 TECHNICIAN TOOK A 041 REPERFUSION CATHETER OUT OF THE PACKAGE AT AN ANGLE AND OBSERVED A BEND IN THE CATHETER. THE HOSPITAL DID NOT HAVE ANOTHER 041 SYSTEM AND INSTEAD USED AN 032 SYSTEM WITH SUCCESS. A PENUMBRA REPRESENTATIVE RETRAINED THE HOSPITAL ON HOW TO FLUSH AND REMOVE CATHETERS FROM THEIR SHIPPING HOOPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 041 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F15983

    Patients

    Seq Age Sex Outcome Treatment
    1