BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1642374 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00391
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    October 15, 2009
    Report Date
    October 17, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THERE ARE TWO OVALIZATIONS WITH DIFFERENT AXES AT THE TIP OF THE CATHETER BETWEEN 2.4 AND 3.5 CM FROM THE DISTAL TIP. THE INCIDENT IS CONFIRMED AS REPORTED. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA 02/2010 UPDATE TO THE FDA WARNING LETTER DATED 12/31/2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 2314-03, (LOT # L15475). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. (B)(4). ALL UNITS PASSED TO STERILIZATION AND SHIPPED WERE SORTED OR REPROCESSED TO MEET SPEC. THE (B)(4) HAS NO BEARING ON THE COMPLAINT IN THIS INCIDENT. 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

    NEURON WAS FOUND TO HAVE A FLATTENED TIP UPON OPENING THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15475

    Patients

    Seq Age Sex Outcome Treatment
    1