BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1621156 · Received March 1, 2010

    Report

    Report Number
    3005168196-2010-00121
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    February 2, 2010
    Report Date
    February 4, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: LOT # F15555: THE FIRST 2.5CM OF THE DISTAL TIP WERE FLATTENED AND TWISTED. THE DHR'S OF THESE MFG LOTS HAVE BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN 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 # 2314-04 (LOT # L15555). 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 SPEC FOR THE TENSILE STRENGTH. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT. THIS LOT WAS ASSOCIATED WITH (B)(4). THE LOT WAS 100% SORTED AND (B)(4) UNITS WERE REJECTED.

    Description of Event or Problem · 1

    THE PHYSICIAN FOUND THAT THE TIP OF THE NEURON CATHETER WAS CRIMPED AND UNUSABLE UPON OPENING THE PACKAGING. THE PHYSICIAN THEN OPENED ANOTHER NEURON AND FOUND THAT TO BE CRIMPED AS WELL. A THIRD UNIT WAS THEN OPENED AND USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15555

    Patients

    Seq Age Sex Outcome Treatment
    1