BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURON DELIVERY CATHETER 070

    MDR report key: 1588945 · Received January 19, 2010

    Report

    Report Number
    3005168196-2010-00036
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    December 29, 2009
    Report Date
    December 29, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082290
    Removal / Correction Number
    Z-0001-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE DEVICE EVAL REVEALED THREE PROXIMAL KINKS, AND TWO DISTAL KINKS. THE REPORTED KINKS OCCURRED AT THE DISTAL 1/3 OF THE DEVICE, AND RESULTED IN THE REDUCTION OF THE INNER DIAMETER OF THE LUMEN OF THE CATHETER, WHICH CREATED RESISTANCE. THE KINKS MAY HAVE OCCURRED BECAUSE OF THE ANATOMY OF THE PT AND RESULTS IN THE MANIPULATION OF THE DEVICE IN SHARP ANGLES. THE PROXIMAL KINKS MAY HAVE BEEN INFLICTED DURING THE RETURN TO PENUMBRA. THE DHR OF THIS MANUFACTURING LOT HAS BEEN REVIEWED AND IS ATTACHED. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED ON PART # 1626-02.B, (LOT # L14102). ALL APPROPRIATE INSPECTIONS WERE COMPLETED PER PROCESS MONITORING REQUIREMENTS OR 100% INSPECTIONS WERE REQUIRED. (B)(4) ALL PARTS RELEASED MET SPECIFICATIONS. THE PARTS RELEASED IN THIS LOT MET PROCESS REQUIREMENT. IN ADDITION, ALL DESTRUCTIVE TESTING WAS COMPLETED PER REQUIRED PROCESS MONITORING REQUIREMENTS AND RESULTS MET SPECIFICATION FOR THE TENSILE STRENGTH. (B)(4)

    Description of Event or Problem · 1

    THE NEURON 070 WAS DEPLOYED TO THE CERVICAL CAROTID ARTERY USING A .035 GUIDEWIRE AND A 5F DIAGNOSTIC CATHETER. WHILE INSERTING AN ECHELON MICROCATHETER AND MIRAGE 008 WIRE, THE PHYSICIAN FELT THE CATHETER STOP AND HE COULD NOT ADVANCE THE CATHETER BEYOND THIS POINT. WHEN THE PHYSICIAN INVESTIGATED, HE FOUND THAT THE NEURON 070 WAS CRIMPED IN THE COMMON CAROTID SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURON DELIVERY CATHETER 070 PERCUTANEOUS CATHETER DQY PENUMBRA, INC. F14102

    Patients

    Seq Age Sex Outcome Treatment
    1