BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1641648 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00343
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    April 3, 2009
    Report Date
    June 23, 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 EVAL: A LARGE FLAT SPOT WAS SEEN BETWEEN 2.7 AND 3.9 CM FROM THE DISTAL TIP AS WELL AS A SINGLE AXIS BEND 4.5 CM FROM THE TIP. IN ADDITION, THERE IS A SEVERE SINGLE AXIS BEND 44.0 CM FROM THE TIP. CONCLUSION: THE INCIDENT IS CONFIRMED AS REPORTED. 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# 1626-01.B, (LOT# L14427). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WHERE REQUIRED. THIS LOT WAS ASSOCIATED WITH (B)(4). THE DHR REVIEW OF FINAL ASSEMBLY (LOT# L14427) INDICATED THAT 100% INSPECTION OF THE DEVICES RESULTED IN (B)(4) REJECTS. ALL PARTS THAT FAILED VISUAL INSPECTION HAVE BEEN REJECTED AND ALL PARTS MET SPECIFICATIONS. IN ADDITION, ALL DESCRIPTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS GOING TO USE THE 070 DELIVERY CATHETER IN A PROCEDURE AND FOUND THE CATHETER KINKED BEFORE INTRODUCTION INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F14427

    Patients

    Seq Age Sex Outcome Treatment
    1