BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1647755 · Received March 29, 2010

    Report

    Report Number
    3005168196-2010-00464
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE FIRST 2.5 CM OF THE DISTAL TIP OF THE CATHETER IS FLATTENED IN TWO DIFFERENT DIRECTIONS. THE INCIDENT IS CONFIRMED AS REPORTED. THE CAUSE OF THE FLATTENING COULD NOT BE DETERMINED. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED. THIS MDR IS BEING FILED BASED ON OUR UNDERSTANDING OF INCIDENT REPORTABILITY AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #2314-03, (LOT #L15738). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN INTRODUCED THE NEURON 070 OVER A 0.035 GLIDEWIRE. THEN HE CROSSED THE AORTIC ARCH WITH THE NEURON 070 AND AS HE WAS SELECTING THE CAROTID ARTERY, HE DISCOVERED (VIA FLUOROSCOPIC IMAGING) THAT THE DISTAL TIP OF THE NEURON CATHETER WAS KINKED. THE KINKED NEURON CATHETER WAS REMOVED AND ANOTHER NEURON WAS USED TO COMPLETE THE COILING CASE. THERE WAS NOT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15738

    Patients

    Seq Age Sex Outcome Treatment
    1