BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 088 SYSTEM

    MDR report key: 2991293 · Received March 6, 2013

    Report

    Report Number
    3005168196-2013-00090
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THIS CATHETER IS KINKED IN THE PROXIMAL PORTION APPROXIMATELY (30.7CM) FROM THE HUB. THE DILATOR IS IN GOOD CONDITION. A 0.088" MANDREL WAS INTRODUCED INTO THE HUB AND ADVANCED DISTALLY UNTIL IT REACHES THE KINKED AREA APPROXIMATELY (27.5 CM) FROM THE HUB. THIS CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE DILATOR WAS INSERTED THROUGH THE HUB OF THE CATHETER AND ADVANCED DISTALLY UNTIL IT REACHED THE KINKED AREA IN PROXIMAL PORTION OF THE SHAFT. THE SHEATH CANNOT BE FULLY INSERTED IN TO THE CATHETER. THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. IT IS LIKELY THAT THE DILATOR COULD NOT BE INSERTED INTO THE CATHETER DUE TO THE KINK IN THE PROXIMAL PORTION OF THE CATHETER SHAFT. THE CAUSE OF THE KINK COULD NOT BE DETERMINED. HOWEVER, IT MAY HAVE OCCURRED DURING REMOVAL FROM THE PACKAGING AND PREPARATION OF THE DEVICE FOR USE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE DILATOR DOES NOT FIT THROUGH THE CATHETER. THE CATHETER MAY BE MISSHAPEN. PRODUCT WAS NOT USED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95235 NEURON MAX 088 SYSTEM DQY DQY PENUMBRA, INC. F29991

    Patients

    Seq Age Sex Outcome Treatment
    1