BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1633451 · Received March 4, 2010

    Report

    Report Number
    3005168196-2010-00114
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    January 28, 2010
    Report Date
    February 8, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THERE WERE SEVERAL SINGLE AXIS BENDS IN THE PROXIMAL SHAFT, THE FIRST AND MOST EXTREME AT 14.5 CM FROM THE HUB/SHAFT JOINT. THERE WERE TWO MORE BENDS IN THE SAME DIRECTION AT 15 AND 15.4 CM FROM THE JOINT AND THE FOURTH BEND ABOUT 45 DEGREES OFF AXIS FROM THE OTHER THREE AT 17 CM FROM THE JOINT. AT THE DISTAL END OF THE CATHETER, THERE WAS AN OVALIZATION AT 8.5 CM FROM THE TIP. THE INCIDENT WAS CONFIRMED AS REPORTED. SINCE THE COMPLAINT WAS ADVANCING THE NEURON THROUGH AN 8F SHEATH AND STILL ENCOUNTERING RESISTANCE HIGHER IN ANATOMY, IT SEEMS LIKELY THAT THE PROXIMAL DAMAGE WAS NOT SEEN UNTIL AFTER THE INCIDENT. THE DHR OF THIS MFG LOT HAS BEEN REVIEWED AND A COPY IS ATTACHED. AS PER FDA GUIDANCE ON 28AUG09, CATHETER KINKS ARE REPORTABLE INCIDENTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 2314-03, (LOT# L15900). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. (B)(4).THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    DURING THE CASE, THE PHYSICIAN WAS ABLE TO ADVANCE THE NEURON 070 INTO THE AORTA THROUGH AN 8F SHEATH BUT FELT RESISTANCE. THE NEURON WOULD NOT ADVANCE PAST THE TRANSITION OF THE CERVICAL SEGMENT AND THE PETROUS SEGMENT OF THE ICA. THE PHYSICIAN NOTED THAT THE VESSELS WERE NOT ELONGATED. THE PHYSICIAN THEN DECIDED TO USE A GUIDING CATHETER FROM ANOTHER COMPANY AND WAS ABLE TO RECANALIZE THE VESSELS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00115.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15900

    Patients

    Seq Age Sex Outcome Treatment
    1