BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1830888 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00263
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    December 17, 2008
    Report Date
    December 17, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE BOX WAS RETURNED WITH SEVERE PHYSICAL DAMAGE IN THE UPPER 1/3 AND MID SECTIONS, THE BOX APPEARED TO BE STEPPED ON OR MISHANDLED. CONCLUSION: THE DEVICE HAD MULTIPLE KINKS THAT WERE IN THE APPROXIMATE LOCATIONS OF THE OUTER BOX DAMAGE, WHICH MAY INDICATE THAT THE DAMAGE NOTICED ON THE DEVICE WAS CAUSED BY HANDLING OF THE BOX DURING TRANSIT AS THE OUTER BOX HAS BEEN SEVERELY DAMAGED. THE DHR FOR THIS MANUFACTURING LOT HAS 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 # 1626-04 NEURON DELIVERY CATHETER 070 (95CM X 6 CM) SHAPED TIP, LOT NUMBER L13773. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L13773) 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) UNITS WERE REJECTED PER (B)(4). DISPOSITION. IN ADDITION, ALL DESTRUCTIVE TESTING WAS 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 REQUIREMENT.

    Description of Event or Problem · 1

    THE DEVICE WAS DAMAGED DURING TRANSIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F13773

    Patients

    Seq Age Sex Outcome Treatment
    1