BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 1644766 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00138
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    October 19, 2007
    Report Date
    October 19, 2007
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: VISUAL: THE CATHETER WAS RETURNED WITH FABRIC TYPE TAPE COVERING THE FRACTURE. THE FRACTURE WAS 17.4 CM FROM THE DISTAL TIP. CONCLUSION: THE ENGINEER WAS UNABLE TO REMOVE TAPE COVERING THE FRACTURE AND WAS UNABLE TO EXAMINE THE FRACTURE SITE TO CONFIRM IT WAS A NECKED FAILURE. THOUGH THIS BREAK IS MORE PROXIMAL THAN THE PREVIOUSLY OBSERVED FAILURES, THIS FAILURE IS LIKELY DUE TO PULLING ON THE CATHETER WITHOUT OPENING THE TABS ON THE PACKAGING CARD. 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 12/31/2009. A REVIEW OF THE DESIGN HISTORY RECORD WAS COMPLETED AND NO ANOMALIES WERE OBSERVED. ALL APPROPRIATE INSPECTIONS WERE COMPLETED. ON THE SUB-ASSEMBLY LEVEL PART #0918-04 (LOT #L11673) NO ANOMALIES WERE OBSERVED DURING DESTRUCTIVE TESTING. SPECIFICALLY 13 PARTS, AS PART OF PROCESS MONITORING WERE TESTED FOR DISTAL JOINT TENSILE STRENGTH, ALL 13 PARTS MET THE ACCEPTANCE CRITERIA (B)(4). ALL OTHER VISUAL AND DIMENSIONAL INSPECTIONS WERE COMPLETED EITHER AT 100% INSPECTION OR A SAMPLE PLAN. THE MANUFACTURED PARTS IN THIS LOT AND THE SUB-ASSEMBLY LEVEL LOT MET THE REQUIRED CRITERIA AND ARE DEEMED ACCEPTABLE.

    Description of Event or Problem · 1

    PHYSICIAN TIP BROKE DURING REMOVAL FROM PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F11817

    Patients

    Seq Age Sex Outcome Treatment
    1