BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA NEURON MAX 6F 088

    MDR report key: 3170191 · Received June 14, 2013

    Report

    Report Number
    3005168196-2013-00238
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 3, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE NEURON MAX 088 HAS A DEFORMED TIP THAT APPEARS TO BE TORN. A 0.088" MANDREL WAS INTRODUCED THROUGH THE HUB OF THE NEURON MAX 088, AND COULD ADVANCE DISTALLY WITHOUT AN ISSUE. THIS NEURON IS NON-FUNCTIONAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT THE PRODUCT WAS DEFECTIVE OUT OF BOX. DURING EVALUATION IT WAS CONFIRMED THAT THE DISTAL TIP OF THE NEURON WAS DAMAGED. AFTER ADDITIONAL INVESTIGATION AND ATTEMPTS TO REPLICATE THE FAILURE MODE, IT WAS DISCOVERED THAT THE TIPS WERE BEING DAMAGED WHEN THE DEVICES WERE PULLED FROM THE PACKAGING. TO REMOVE THE CATHETER FROM THE PACKAGING, CUSTOMERS TYPICALLY OPEN THE BOX, PEEL BACK THE STERILE ENVELOPE AND GRIP THE HUB END OF THE DEVICE AND PULL. WHEN REMOVING THE DEVICE IN THIS MANNER, IT WAS FOUND THAT THE PACKAGING MANDREL IN THE DISTAL TIP OF THE DEVICE CAN COME LOOSE FROM THE PACKAGING CARD AND INTERACT WITH THE EDGE OF THE SHIPPING TUBE, CAUSING THE TIP OF THE CATHETER TO BECOME PINCHED BETWEEN THE INNER WALL OF THE SHIPPING TUBE AND THE SHIPPING MANDREL. WHEN THE USER CONTINUES TO PULL, THE POLYMER OF THE CATHETER TIP CAN EVENTUALLY YIELD AND TEAR BEFORE THE DEVICE COMES COMPLETELY OUT OF THE PACKAGING TUBE, CAUSING THE REPORTED DAMAGE TO THE TIP OF THE CATHETER. THIS ISSUE OCCURS DUE TO A FAILURE OF THE STICKER ADHESIVE THAT IS INTENDED TO HOLD THE PACKAGING MANDREL SECURELY IN PLACE. THE AFFECTED DEVICES CONTAINED STICKERS THAT WERE NOT SUFFICIENTLY SECURING THE MANDREL IN PLACE DURING REMOVAL OF THE NEURON MAX MP. THIS ISSUE IS BEING ADDRESSED UNDER CAPA (B)(4). THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HAS BEEN RETURNED, BUT IS PENDING INVESTIGATION. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    NEURON MAX 088 CATHETER WAS NOTED TO BE DEFECTIVE BEFORE BEING OPENED BY THE LAB MANAGER. IT WAS REPORTED THAT THE PLASTIC PORT ON THE CATHETER WAS DEFORMED. THE CATHETER DID NOT COME INTO PATIENT CONTACT, AND ANOTHER ONE WAS USED FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272115 PENUMBRA NEURON MAX 6F 088 DQY DQY PENUMBRA, INC. F31824

    Patients

    Seq Age Sex Outcome Treatment
    1