BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 053

    MDR report key: 2103391 · Received May 17, 2011

    Report

    Report Number
    3005168196-2011-00217
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 20, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    DQY
    PMA / PMN Number
    K070970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE PENUMBRA NEURON DELIVERY CATHETER 053 OVER AN EXCHANGE LENGTH GLIDEWIRE WHILE WORKING IN THE LEFT SUBCLAVIAN ARTERY. THE GLIDEWIRE WAS IN THE V2 SEGMENT OF THE LEFT VERTEBRAL ARTERY AND THE PHYSICIAN WAS TRYING TO PLACE THE NEURON IN THE VERTEBRAL ARTERY. THE VESSELS WERE EXTREMELY TORTUOUS, AND THE PHYSICIAN WAS UNABLE TO ACCESS THE ARTERY SO HE REMOVED THE NEURON AND GLIDEWIRE. AS HE REMOVED THE DEVICES, HE NOTICED A STRING OR "FUZZ" THAT LOOKED LIKE SOMETHING WAS UNRAVELING. THE WIRE WAS INTACT, SO THE PHYSICIAN THOUGHT IT CAME FROM THE DISTAL TIP OF THE NEURON. THERE WAS NO PATIENT INJURY. THE HOSPITAL THREW AWAY THE NEURON AND THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 053 DQY PENUMBRA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR