BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1588979 · Received January 19, 2010

    Report

    Report Number
    3005168196-2010-00006
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    January 23, 2009
    Report Date
    January 23, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Removal / Correction Number
    Z-0001-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE KINK REPORTED IN THE INCIDENT DESCRIPTION OCCURRED 14.5 CM FROM THE TIP AND COLLAPSED THE CATHETER LUMEN. THERE IS AN INDICATION THAT THE DEVICE MAY HAVE BEEN BENT TOO FAR IN A SHARP ANGLE DUE TO THE TORTUOUS ANATOMY OF THE PT AS REFERENCED IN THE INCIDENT DESCRIPTION. THE KINK REDUCED THE CATHETER'S INNER DIAMETER, CREATING RESISTANCE AT THE LOCATION OF THE KINK. ADDITIONAL KINKS TO THE DEVICE WERE LIKELY CAUSED DURING TRANSIT WHEN THE DEVICE WAS RETURNED TO PENUMBRA FOR EVAL. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED AND IS ATTACHED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN IN RESPONSE TO THE 483 ISSUED TO PENUMBRA ON (B)(4) 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 1626-02 NEURON DELIVERY CATHETER 070 (95CM X 6CM) SHAPED TIP, LOT NUMBER L13751. THE LOT WAS BUILT AT RISK UNDER FDA 069 FOR 1 YEAR ACCELERATED AGING DATA NOT BACK YET. THE LOT WAS AFFILIATED WITH NCR 664 FOR COATING LENGTH OUT OF SPECIFICATION PER MQI 1499. LOT WAS RECOATED PER NCR 664 AND 66 UNITS WERE ACCEPTED AND 48 SCRAPPED. (B)(4). IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. ALL PARTS THAT FAILED INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. NO OTHER ANOMALIES WERE FOUND WITH THIS LOT DUE TO THE MANUFACTURING PROCESS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN TRIED TO ADVANCE THE 070 NEURON OVER A .014 GUIDE WIRE, BUT COULD NOT MAKE THE TURN AROUND THE FIRST PROXIMAL LOOP IN THE CERVICAL ICA. HE THEN REMOVED THE GUIDE WIRE AND TRIED TO ADVANCE THE NEURON CATHETER OVER THE .014 WIRE IN CONJUNCTION WITH A MICRO CATHETER. AS HE WAS BEGINNING TO INTRODUCE THE MICRO CATHETER SYSTEM, HE ENCOUNTERED SIGNIFICANT RESISTANCE IN THE NEURON CATHETER. HE THEN PULLED OUT THE ENTIRE SYSTEM FROM THE PT, INCLUDING THE NEURON WHERE HE THEN NOTICED A KINK IN THE NEURON CATHETER APPROXIMATELY 14 CM FROM THE DISTAL TIP. AN ENVOY CATHETER WAS THEN SELECTED AND THE CASE WAS SUCCESSFUL COMPLETED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F13751

    Patients

    Seq Age Sex Outcome Treatment
    1