BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070 ADV.

    MDR report key: 1641682 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00335
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    June 10, 2009
    Report Date
    June 10, 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: BOTH CATHETERS WERE EXAMINED AND FOUND TO HAVE AN OVALIZATION AT THE SAME POINT ON THE PROXIMAL SECTION OF THE SHAFT. THE OVALIZATIONS ARE 0.5CM LONG AND CENTERED 36.5 CM FROM THE DISTAL TIP. CONCLUSION: THE INCIDENT IS CONFIRMED AS REPORTED. THE UNITS WERE THREADED BACK INTO THE PROTECTIVE TUBE ATTACHED TO THE CARRIER CARD. WHEN THE OVALIZATION WAS INTRODUCED INTO THE TUBE RESISTANCE WAS FELT. CLOSE EXAMINATION OF THE ONE CARD RETURNED SHOWS A BEND AT THE POINT THE OVALIZATION OCCURRED. 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 # 2314-03.A, (LOT # L15252). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L15252) INDICATED THAT INSPECTION OF THE DEVICES RESULTED IN 28 REJECTS FOR VISUAL AND DIMENSIONAL MEASUREMENT. THIS LOT WAS ASSOCIATED WITH (B)(4) WHICH REQUIRED ADDITIONAL TESTING TO INCREASE PROCESS MONITORING. 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

    UPON REMOVING THE CATHETERS FROM THE OUTER PACKAGING, BOTH CATHETERS WERE FOUND TO HAVE KINKS AT THE MIDSECTION OF THE CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 ADV. PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15252

    Patients

    Seq Age Sex Outcome Treatment
    1