BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 68 HI-FLOW KIT

    MDR report key: 6937898 · Received October 10, 2017

    Report

    Report Number
    3005168196-2017-01765
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 15, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548016597
    PMA / PMN Number
    K161640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE ACE68 WAS KINKED APPROXIMATELY 28.0, 79.0, 80.0, AND 91.0 CM FROM THE HUB, HOWEVER; FLUID WAS ASPIRATED THROUGH THE ACE68 WITHOUT ISSUE. "510(K) #¿ TO K161640.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WAS KINKED APPROXIMATELY 28.0, 79.0, 80.0, AND 91.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED ACE68 CONFIRMED IT WAS KINKED. THIS DAMAGE MAY HAVE OCCURRED DUE TO FORCEFUL MANIPULATION OF THE ACE68 DURING NAVIGATION OF PATIENT ANATOMY OR ADVANCEMENT THROUGH THE NEURON MAX. THE OBSERVED KINK LIKELY CONTRIBUTED TO THE LACK OF ASPIRATION REPORTED IN THE COMPLAINT. THE NEURON MAX MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. PENUMBRA CATHETERS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA)/MIDDLE CEREBRAL ARTERY (MCA) TO TREAT AN ISCHEMIC STROKE USING PENUMBRA SYSTEM ACE 68 HI-FLOW KITS (KITS). DURING THE PROCEDURE, WHILE USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE ASPIRATION STOPPED WORKING; THEREFORE, THE ACE68 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE ACE68 WAS KINKED AROUND THE MID-SHAFT. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW KIT 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
    715119 PENUMBRA SYSTEM ACE 68 HI-FLOW KIT NRY NRY PENUMBRA, INC. F70596 00814548016597

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR