BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1641708 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00292
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    February 9, 2009
    Report Date
    February 10, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL. THE KINK WAS LOCATED APPROX 23CM FROM THE HUB. THE DEVICE WALLS DID NOT COLLAPSE AND THE INTEGRITY OF THE DEVICE WAS MAINTAINED AT THE LOCATION. THERE WERE ADDITIONAL KINKS NOTED, HOWEVER, THESE KINKS WERE INFLICTED BECAUSE OF THE SHIPPING CONDITIONS UPON RETURN TO PENUMBRA. THE KINK MENTIONED IN THE COMPLAINT IS ACTUALLY A SMALL DEFORMITY IN THE ROUNDNESS OF THE DEVICE. 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 # 1626-02 NEURON DELIVERY CATHETER 070 (95CM X 6 CM) STRAIGHT TIP, LOT NUMBER L13751. THE DHR REVIEW OF FINAL ASSEMBLY (LOT # L13751) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN 7 VISUAL REJECTS POST COATING. ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. A REVIEW OF THE COIL SUB-ASSEMBLY LOTS USED TO MFR LOT L13751 SHOW NO ANOMALIES WITH THE MFG PROCESS, HOWEVER, SOME UNITS HAVE BEEN REJECTED DURING VISUAL INSPECTION (L13873 (8 REJECTS); L13873 (3 REJECTS); L13876 (5 REJECTS)); THE 3 LOTS PASSED ALL THE REQUIRED VISUAL INSPECTION AND DIMENSIONAL MEASUREMENTS. 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 MFG PROCESS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE NEURON 070 WAS PULLED FROM THE PACKAGING AND A KINK WAS NOTICED PRIOR TO ITS USE IN A PT. THEY PULLED ANOTHER ONE AND IT WAS OKAY. ADDITIONAL KINKS WERE CAUSED BY INSERTING IT INTO THE BIO BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F13751

    Patients

    Seq Age Sex Outcome Treatment
    1