BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1873454 · Received September 17, 2010

    Report

    Report Number
    3005168196-2010-00631
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    March 31, 2009
    Report Date
    March 31, 2009
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE UNIT WAS RETURNED IN ITS STERILE POUCH, UNOPENED. THERE ARE 2 POINTS OF DAMAGE, ONE AT 1.5CM AND THE SECOND AT 3.0CM FROM THE DISTAL TIP. CAREFUL EXAMINATION OF THE PACKAGE SHOWS A CREASE IN THE CARDBOARD CATHETER CARRIER. CONCLUSION: THE PACKAGE APPEARS TO HAVE BEEN MISHANDLED AT SOME POINT PRIOR TO USE. THE PHYSICIAN REPORTED TO PENUMBRA ENGINEERING THAT WHILE THE UNITS WERE BEING UNBOXED BUT STILL IN THEIR STERILE POUCHES, THEY WERE DROPPED ON THEIR DISTAL TIPS AND THE PACKAGING BENT. ATTEMPTS TO DUPLICATE THESE CONDITIONS AT PENUMBRA HAVE NOT BEEN SUCCESSFUL. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    UPON REMOVING THE NEURON CATHETER FROM THE PACKAGING, A KINK IN THE DISTAL TIP WAS NOTICED. PRODUCT WAS PLACED BACK INTO THE PACKAGING AND A NEW NEURON WAS REMOVED FROM INVENTORY. THREE OTHER NEURONS WERE DISCOVERED TO HAVE A KINK IN THE SAME LOCATION. THERE WAS NO VISUAL DAMAGE TO THE OTHER PACKAGING (BOX). ONE CATHETER IN THE NON OPENED PACKAGING IS BEING RETURNED FOR INSPECTION. THE OTHER CATHETERS WERE REMOVED FROM PACKAGING BUT FROM HANDLING CAUSED MANY KINKS IN THE SHAFT. PLEASE FOCUS ON THE DISTAL ENDS ONLY. THIS MDR IS ASSOCIATED WITH MDR3005168196-2010-00313, MDR3005168196-2010-00629, MDR3005168196-2010-00630.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA INC. F13980

    Patients

    Seq Age Sex Outcome Treatment
    1