BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 1644688 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00150
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    April 9, 2008
    Report Date
    April 10, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE CATHETER HAD THREE KINKS ALONG THE DISTAL FLEXIBLE LENGTH. CONCLUSION: SINCE THE PHYSICIAN NOTICED THE KINKS UPON REMOVAL FROM THE PACKAGING, THE KINK LIKELY OCCURRED DURING THE MANUFACTURING PROCESS. THE DHR OF 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 WAS COMPLETED ON PART # 1097-04 (LOT # L12211). THE SUBASSEMBLY FOR THIS PART (P/N 0918-04, LOT # L11993, (B)(4)) WAS ALSO REVIEWED. ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATIONS. NO ANOMALIES WERE FOUND WITH THIS LOT. THE PARTS MANUFACTURED IN THIS LOT MET THE REQUIRED CRITERIA AND ARE DEEMED ACCEPTABLE.

    Description of Event or Problem · 1

    UPON REMOVING THE NEURON FROM THE PACKAGING, A KINK IN THE DISTAL TIP OF THE CATHETER WAS NOTICED. THE PHYSICIAN LEFT THE NEURON INSIDE THE PACKAGING AND REMOVED ANOTHER DEVICE FROM THEIR INVENTORY AND CONTINUED WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F12211

    Patients

    Seq Age Sex Outcome Treatment
    1