BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 68 HI-FLOW KIT

    MDR report key: 7100409 · Received December 8, 2017

    Report

    Report Number
    3005168196-2017-02167
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 10, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548016603
    PMA / PMN Number
    K161640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO SECTION: CORRECTED "510(K) #¿ TO K161640.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WAS OVALIZED APPROXIMATELY 106.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED ACE68 REVEALED IT WAS OVALIZED. THIS DAMAGE MAY HAVE OCCURRED DUE TO FORCEFUL MANIPULATION OF THE ACE68 DURING NAVIGATION OF PATIENT ANATOMY. 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 TO TREAT AN ACUTE ISCHEMIC STROKE USING A PENUMBRA SYSTEM ACE 68 HI-FLOW KIT (KIT). DURING THE PROCEDURE, A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 V (PUMP MAX) WAS TURNED ON, AND ASPIRATION BEGAN FOR APPROXIMATELY 90 SECONDS USING THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). AFTER THAT, WHILE USING DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT), THE PHYSICIAN WITHDREW THE ACE68 TO VISUALLY INSPECT THE CLOT; UPON REMOVING THE ACE68 FROM THE PATIENT, THE PHYSICIAN NOTICED THAT IT WAS KINKED. THEREFORE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880277 PENUMBRA SYSTEM ACE 68 HI-FLOW KIT NRY NRY PENUMBRA, INC. F78619 00814548016603

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR