BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2970585 · Received February 20, 2013

    Report

    Report Number
    3005168196-2013-00064
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 21, 2013
    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

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THE CATHETER WAS BROKEN APPROXIMATELY (25.7 CM) FROM THE HUB IN THE PROXIMAL SECTION OF THE CATHETER. THIS CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT THE CATHETER WAS BROKEN DURING REMOVAL FROM PACKAGING. THIS DAMAGE LIKELY OCCURRED DUE TO MISHANDLING WHEN REMOVING THE PRODUCT FROM THE PACKAGING. IF THE CATHETER IS REMOVED FROM THE CARRIER HOOP AT AN ANGLE, IT MAY CAUSE RESISTANCE OR FRICTION, LEADING TO A KINK OR A BREAK IN THE CATHETER. 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

    THE REPERFUSION CATHETER 032 WAS BROKEN WHEN IT WAS BROUGHT OUT OF THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74388 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR