BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED NEURON DELIVERY CATHETER 070

    MDR report key: 2625557 · Received October 2, 2009

    Report

    Report Number
    3005168196-2009-00076
    Event Type
    Malfunction
    Date Received
    October 2, 2009
    Date of Event
    September 3, 2009
    Report Date
    October 2, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR FOR THIS MFG LOT HAS BEEN REVIEWED AND THIS REVIEW IS ATTACHED. THIS IS AN INITIAL REPORT PENDING OUR RECEIPT OF THE DEVICE FOR ANALYSIS. INCIDENT #: (B)(4). PART # 2314-01.A. NEURON DC 070 105CMX8CM, STRAIGHT TIP. LOT #F15235 (SAME AS L15234). QTY: 1. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART #2314-01.A, (LOT # L15234). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THIS LOT WAS ASSOCIATED WITH (B)(4). IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOT THE TENSILE STRENGTH. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    AFTER UNPACKING THE CATHETER, THE PHYSICIAN NOTICED THAT THE TIP WAS KINKED. THE DEVICE WILL BE RETURNED FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15234

    Patients

    Seq Age Sex Outcome Treatment
    1