BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070 ADVANCED

    MDR report key: 1544929 · Received November 6, 2009

    Report

    Report Number
    3005168196-2009-00089
    Event Type
    Malfunction
    Date Received
    November 6, 2009
    Date of Event
    October 9, 2009
    Report Date
    October 9, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THERE WERE A VARIETY OF FLAT SPOTS COVERING THE FIRST 10CM OF THE DISTAL TIP OF THE CATHETER. THE FIRST WAS BETWEEN 0.0 AND 1.2CM FROM THE TIP, FOLLOWED BY FLAT SPOTS BETWEEN 1.9-3.4, 4.5-6.5, AND 7.5-10.2CM FROM THE TIP. A 0.041" MANDREL WAS INSERTED INTO THE HUB AND PASSED THROUGH THE CATHETER WITH NO FRICTION. THE PROCESS WAS REPEATED WITH A 0.053" MANDREL. SLIGHT FRICTION WAS NOTED IN THE LAST 10CM. THE INCIDENT WAS CONFIRMED AS REPORTED. THE 070 NEURON CATHETER SEEMED TO HAVE BEEN HANDLED ROUGHLY PRIOR TO INTRODUCTION INTO THE PATIENT. ANY OVALIZATION AT THE TIP PRIOR TO INTRODUCTION CAN LEAD TO UNACCEPTABLE FRICTION AND FAILURE TO PASS THE CATHETER. CONCLUSION: AS PER FDA GUIDANCE ON 28 AUG 2009, KINKS ARE REPORTABLE INCIDENTS. QTY:1 - A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 2314-02.A, (LOT # L15336). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. 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

    WHEN THE PHYSICIAN TRIED TO INSERT THE NEURON CATHETER OVER A TERUMO 0.035 GLIDEWIRE INTO A TERUMO 6F SHEATH THE NEURON WOULD NOT SLIDE OVER THE WIRE AND GO INTO THE SHEATH. THE PHYSICIAN THEN PULLED THE NEURON OFF OF THE WIRE AND INSERTED ANOTHER CATHETER. NO PATIENT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 ADVANCED SUBCUTANEOUS CATHETER DQY PENUMBRA, INC. F15336

    Patients

    Seq Age Sex Outcome Treatment
    1