BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1873585 · Received September 17, 2010

    Report

    Report Number
    3005168196-2010-00639
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    June 30, 2009
    Report Date
    July 8, 2009
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE FIRST UNIT WAS OVALIZED AND FLATTENED ON THS DISTAL TIP. THE SECOND UNIT WAS ALSO OVALIZED AND HAD SINGLE AXIS BENDS ON THE DISTAL TIP. THERE WERE OTHER KINKS VISIBLE ON THE PROXIMAL SHAFT AS WELL AS A 45 DEGREE BEND IN THE STRAIN RELIEF, BUT THESE APPEAR TO BE ARTIFACTS OF POST-INCIDENT HANDLING. CONCLUSION: THE INCIDENT IS CONFIRMED BUT NOT AS REPORTED. THE KINKING AT THE DISTAL ENDS OF THE CATHETERS WOULD HAVE PREVENTED THEIR PASSAGE INTO THE INTRODUCER SHEATH. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED (B)(6), 2009.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO USE A NEURON 070 BUT WHEN INSERTING THE CATHETER INTO THE SHEATH, FOUND THAT THE INTRODUCER PROVIDED WAS TOO SMALL FOR THE NEURON AND IT PINCHED THE END FOR THE CATHETER. HE THEN OPENED ANOTHER NEURON 070 AND THE SAME THING HAPPENED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-353.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA INC. F15318

    Patients

    Seq Age Sex Outcome Treatment
    1