BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ENGINE

    MDR report key: 11939356 · Received June 4, 2021

    Report

    Report Number
    3005168196-2021-01251
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 6, 2021
    Report Date
    July 12, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948020023
    PMA / PMN Number
    K180105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED ENGINE REVEALED A FUNCTIONAL DEVICE. DURING FUNCTIONAL TESTING, THE ENGINE WAS TESTED WITH A DEMONSTRATION CANISTER AND WAS ABLE TO ACHIEVE VACUUM PRESSURE WITHIN SPECIFICATION AND ALL FOUR VACUUM INDICATOR LIGHTS ILLUMINATED. THERE WAS NO OBSERVATION OF THE ENGINE VIBRATING ALONG THE TABLE AND THE REPORTED BROKEN VACUUM RELEASE LEVER WAS UNABLE TO BE CONFIRMED. FURTHER EVALUATION REVEALED ONE OF THE FIVE RUBBER FEET ON THE BOTTOM OF THE ENGINE WAS MISSING. THIS DAMAGE MAY BE INCIDENTAL TO THE REPORTED COMPLAINT. PENUMBRA ENGINES ARE INSPECTED AT INCOMING QUALITY CONTROL WHICH INCLUDES A VISUAL INSPECTION AS WELL AS A VERIFICATION OF TEST RESULTS TO ENSURE SPECIFICATIONS FOR EACH OUTPUT ARE MET. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE ENGINE FELL OFF THE TABLE DUE TO VIBRATIONS THEREBY CAUSING THE VACUUM RELEASE LEVER TO BREAK. THE PUMP FELL PRIOR TO THE CATHETER BEING ADVANCED INTO THE PATIENT. THE FOUR LED LIGHTS WERE ON AND THE PHYSICIAN FOUND THE ENGINE TO BE FUNCTIONAL. THE PROCEDURE WAS COMPLETED USING THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838549 PENUMBRA ENGINE QEW QEW PENUMBRA, INC. PMXENGN-A 00815948020023

    Patients

    Seq Age Sex Outcome Treatment
    1