BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER

    MDR report key: 7118000 · Received December 14, 2017

    Report

    Report Number
    3005168196-2017-02205
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 15, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K161640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED "510(K) #¿ TO K161640.

    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. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE THE ACE68 WAS BEING ADVANCED THROUGH THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), IT BECAME KINKED AT THE MID SHAFT. THEREFORE, THE ACE68 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898851 PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1