BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ENGINE

    MDR report key: 10657867 · Received October 9, 2020

    Report

    Report Number
    3005168196-2020-01689
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 12, 2020
    Report Date
    September 17, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948020023
    PMA / PMN Number
    K180105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2020-01689 1. SECTION H. BOX 6. DEVICE CODE 1 EVALUATION OF THE RETURNED ENGINE REVEALED A FUNCTIONAL DEVICE. DURING THE FUNCTIONAL TEST, THE ENGINE WAS POWERED ON AN ACHIEVED VACUUM WITHIN SPECIFICATION. ALL FOUR VACUUM INDICATOR LIGHTS WERE ILLUMINATED. THE ENGINE REMAINED POWERED ON FOR A HALF AN HOUR AND NO ISSUES WERE OBSERVED. THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. 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 IN THE LEFT FEMORAL VEIN USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE ENGINE WAS UNABLE TO PRODUCE FULL ASPIRATION AND THE INDICATOR LIGHTS ON THE ENGINE WOULD ONLY ILLUMINATE UP TO TWO LIGHTS. THE ENGINE WAS THEN TURNED OFF AND TURNED BACK ON TO ACHIEVE ASPIRATION WITH ALL FOUR INDICATOR LIGHTS ILLUMINATED; HOWEVER, ALL FOUR LIGHTS ON THE ENGINE WOULD NOT CONSISTENTLY STAY ILLUMINATED. 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
    1119472 PENUMBRA ENGINE QEW QEW PENUMBRA, INC. PMXENGN-A 00815948020023

    Patients

    Seq Age Sex Outcome Treatment
    1