BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1633441 · Received March 4, 2010

    Report

    Report Number
    3005168196-2010-00130
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 9, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE DISTAL TIP IS DAMAGED WITH A FLAT SPOT BETWEEN 1.0 AND 2.0CM AND A GROUP OF SINGLE-AXIS BENDS ALL IN THE SAME PLANE BETWEEN 2.0 AND 3.5CM. IN ADDITION, THERE IS SOME OVALIZATION MORE DISTAL ON THE CATHETER. THE INCIDENT IS CONFIRMED AS REPORTED. ANY OF THE ABOVE DAMAGE COULD HAVE MADE PASSING THE NEURON THROUGH THE SHEATH DIFFICULT. IT IS DIFFICULT TO TELL WHICH DAMAGE IS RESPONSIBLE FOR THE COMPLAINT. THE INCIDENT DESCRIPTION DOES NOT MENTION ANY DAMAGED NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING; THEREFORE, IT IS POSSIBLE THAT THE DAMAGE SEEN WAS CAUSED BY USER HANDLING. AS PER FDA GUIDANCE ON 08/28/2009, 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. THIS LOT WAS PROCESSED UNDER (B)(4). THIS DA ALLOWED 053 AND 070 NEURONS TO BE BUILT WITH SHIPPING MATERIALS AND HELD FOR SHIPMENT UNTIL THE PROCESS VALIDATIONS WERE COMPLETE. 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 WAS PERFORMING A COILING CASE AND WAS UNABLE TO INTRODUCE THE NEURON INTO A 6F SHEATH. HE USED ANOTHER NEURON AND WAS SUCCESSFULLY. THE CASE WENT WELL AND THE DEVICE HAD NO PATIENT CONTACT.

    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