BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1633471 · Received March 4, 2010

    Report

    Report Number
    3005168196-2010-00129
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Report Date
    February 2, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE DISTAL 18 CM OF THE CATHETER IS FLATTENED TO VARYING DEGREES. THERE IS ALSO A FLAT SECTION BETWEEN 11.5 AND 12.0 CM AND BETWEEN 14.0 AND 18.0 CM FROM THE DISTAL TIP. CONCLUSION: THE INCIDENT IS CONFIRMED AS REPORTED. THE DISTAL TIP IS DEFORMED AND CANNOT BE INTRODUCED OR USED IN ITS CURRENT CONDITION. THE REPORT ALSO STATES THAT THE CATHETER WAS STEPPED ON POST-INCIDENT WHICH MAKES IT IMPOSSIBLE TO DETERMINE WHICH OF THE DAMAGES CAUSED THE DIFFICULTY INTRODUCING THE CATHETER. THE DHR OF THIS MFG LOT HAS BEEN REVIEWED. AS PER FDA GUIDANCE ON (B)(4) 2009, CATHETER KINKS ARE REPORTABLE INCIDENTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 2314-01, (LOT# L15661). 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 SPEC. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS RELEASED MET SPECS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN COULD NOT PASS THE DISTAL TIP OF THE NEURON INTO THE RHV DURING THE CASE. THERE WAS NO PT INJURY. THE HOSPITAL STATED THAT THEY USE THIS DEVICE ROUTINELY AND DO NOT USUALLY HAVE THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15661

    Patients

    Seq Age Sex Outcome Treatment
    1