BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1642426 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00351
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    July 6, 2009
    Report Date
    July 7, 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: THERE WAS A KINK/FLAT SPOT BETWEEN 1.5 AND 2.5CM FROM THE DISTAL TIP. THIS JAMMED IN THE PROTECTIVE TUBING WHEN THE CATHETER WAS REMOVED. CONCLUSION: THE INCIDENT WAS CONFIRMED AS REPORTED. THE DHR OF THIS MFG LOT HAS BEEN REVIEWED. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA 02/2010 UPDATE TO THE FDA WARNING LETTER DATED 12/31/2009. 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 WERE REQUIRED. (B)(4). THIS LOT WAS ASSOCIATED WITH (B)(4) WHICH REQUIRED ADD'L TESTING TO INCREASE PROCESS MONITORING. 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. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE DISTAL TIP OF THE CATHETER WAS DAMAGED IN THE PACKAGE AT THE JUNCTION WHERE THE PROTECTIVE TUBE ENDS. A SECOND CATHETER WAS REMOVED FROM INVENTORY AND UTILIZED FOR COMPLETION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1