BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADV. NEURON DELIVERY CATHETER 070

    MDR report key: 1641675 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00328
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    May 19, 2009
    Report Date
    May 19, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE RETURNED UNIT HAD TWO SINGLE-AXIS BENDS AT 21.6 CM AND 24.8 CM FROM THE END OF THE HYPO TUBE STRAIN RELIEF. A 48.6 CM FROM THE DISTAL TIP THERE IS AN OVALIZATION. IN ADDITION, THERE IS AN OVALIZATION AT 23.5 CM FROM THE DISTAL TIP. CONCLUSION: THE INCIDENT IS CONFIRMED AS REPORTED. THE DHR REVIEW OF THIS MFG LOT WAS PERFORMED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEB 2010 UPDATE TO THE FDA WARNING LETTER DATED DEC 31, 2009. 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. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L15234) INDICATED THAT INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS FOR VISUAL AND DIMENSIONAL MEASUREMENT. THIS LOT WAS ASSOCIATED WITH (B)(4). 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.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED A KINK IN THE CATHETER WHEN IT WAS REMOVED FROM THE POUCH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1