BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 2834569 · Received November 15, 2012

    Report

    Report Number
    3005168196-2012-00383
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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 IS BROKEN IN TWO PIECES. CONCLUSION: THE COMPLAINT IS CONFIRMED. BASED ON THE OBSERVATIONS DURING THE EVALUATION AND THE DESCRIPTION OF THE EVENT, THE CATHETER WAS LIKELY DAMAGED DURING REMOVAL FROM THE PACKAGE. THE TIP OF THE CATHETER DOES NOT APPEAR TO BE STUCK ON THE PACKAGING MANDREL. THERE IS NOTHING HOLDING THE CATHETER THAT WOULD HAVE KEPT IT FROM BEING REMOVED FROM THE PACKAGE OR CREATED RESISTANCE. DEPENDING ON HOW THE CATHETER WAS HANDLED DURING UNPACKAGING, IT IS POSSIBLE THAT THE USER ATTEMPTED TO PULL THE CATHETER FROM THE SHIPPING TUBE BEFORE THE PACKAGING MANDREL WAS REMOVED. BASED ON THE CRUSHED TIP OF THE CATHETER, IT IS ALSO POSSIBLE THAT THE USER ACCIDENTLY HELD THE CATHETER TIP IN PLACE WHILE PULLING ON THE HUB END DURING REMOVAL FROM THE SHIPPING TUBE. 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 NURSE DESCRIBED THAT THE CATHETER WAS DAMAGED WHEN REMOVED FROM THE PACKAGE. THERE WAS SOME KIND OF STRING NOTED AS WELL AS RESISTANCE WHEN REMOVING THE CATHETER. THE CATHETER WAS DESCRIBED AS HAVING A CRUSHED TIP WITH THE INCORRECT TIP SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 DQY DQY PENUMBRA, INC. F26599

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR