BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1644746 · Received March 16, 2010

    Report

    Report Number
    3005168196-2010-00449
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    January 18, 2010
    Report Date
    January 27, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVAL: THE DISTAL 6CM OF THE CATHETER TIP WAS FLATTENED AND CRUMPLED. THERE ARE FINGER-TIP SIZED FLAT SPOTS ALONG THE DISTAL TIP AS WELL AS SINGLE-AXIS BENDS. CONCLUSION: THE INCIDENT WAS CONFIRMED AS REPORTED. THE INCIDENT REPORT NOTES THAT THE PHYSICIAN DID NOT USE THE INCLUDED INTRODUCER SHEATH AND ASCRIBES THE TIP DAMAGE TO THIS FACT. 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, (LOT # L15738). 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 SPEC. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN TRIED TO INTRODUCE THE NEURON IN A 6F TERUMO SHEATH. HE DID NOT USE THE TRANSPARENT "PEEL-AWAY" SHEATH FOR INTRODUCTION "PROPERLY" INTO THE VALUE. THE PHYSICIAN KINKED THE DISTAL PART OF THE NEURON BY TRYING TO PUSH IT WITH HIS FINGERS CAUSING SEVERAL FLAT PORTIONS ON THE DISTAL TIP OF THE NEURON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F15738

    Patients

    Seq Age Sex Outcome Treatment
    1