BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 1830703 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00181
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE RETURNED DEVICE WAS FOUND TO HAVE A FRACTURE AT THE DIAMETER CHANGE JUNCTION. CONCLUSION: THE ROOT CAUSE COULD BE RELATED TO A POOR LAMINATION THAT OCCURRED DURING THE MANUFACTURING PROCESS. THE DHR FOR THIS MANUFACTURING LOT WAS REVIEWED AND A COPY IS ATTACHED. 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 # 1097-04/A (LOT # L12961) AND SUB-ASSEMBLY (B)(4) (LOT# L12794). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L12961) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN ((B)(4) VISUAL REJECT. THE DHR REVIEW OF SUB-ASSEMBLY PN0918-04/A LOT# L12794) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4)VISUAL REJECTS POST HUB MOLDING AND 1 VISUAL REJECT POST COATING. 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 MFG PROCESS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    UPON REMOVING THE NEURON FROM THE PACKAGING, THE DISTAL TIP OF THE CATHETER SEPARATED FROM THE REST OF THE BODY OF THE DEVICE. THE PHYSICIAN REMOVED THE CATHETER FROM THE TABLE AND TOOK ANOTHER NEURON FROM INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F12961

    Patients

    Seq Age Sex Outcome Treatment
    1