BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1626275 · Received February 11, 2010

    Report

    Report Number
    3005168196-2010-00104
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    December 4, 2008
    Report Date
    December 4, 2008
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Removal / Correction Number
    Z-0001-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN IN RESPONSE TO THE 483 ISSUED TO PENUMBRA ON AUGUST 28, 2009. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 1626 -07 NEURON DELIVERY CATHETER 070 (95CM X 6 CM) SHAPED TIP, LOT NUMBER L13799. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L13799) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS. THE LOT WAS SORTED FOR DAMAGED TIP DURING PACKAGING PER (B)(4) AND (B)(4) WERE REJECTED PER (B)(4) DISPOSITION. IN ADDITION, ALL DESTRUCTIVE TESTINGS WERE COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. 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 REQUIREMENTS.

    Description of Event or Problem · 1

    THE NEURON KINKED NEAR THE HUB OF THE CATHETER AND THE PRODUCT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA INC. F13799

    Patients

    Seq Age Sex Outcome Treatment
    1