BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 1830720 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00200
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 1097-02 (LOT # L12661) AND SUB-ASSEMBLY PN0918-02/A (LOT # L12507). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT # L12661) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN NO VISUAL REJECTS; ALL LOT PASSED 100% VISUAL INSPECTION. THE DHR REVIEW OF SUB-ASSEMBLY PN0918-02/A (LOT # L12507) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN 10 VISUAL REJECTS POST HUB MOLDING AND 3 VISUAL REJECTS POST COATING. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. VISUAL FAILURE COULD NOT BE ATTRIBUTED TO THE INCIDENT AS ALL PARTS THAT FAILED VISUAL 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 NOTICED THAT THE NEURON HAD A FLATTENED TIP UPON OPENING THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F12661

    Patients

    Seq Age Sex Outcome Treatment
    1