BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP CANISTER WITH LID

    MDR report key: 1410095 · Received July 6, 2009

    Report

    Report Number
    3005168196-2009-00030
    Event Type
    Death
    Date Received
    July 6, 2009
    Date of Event
    June 29, 2009
    Report Date
    July 6, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KDQ
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP SET UP GUIDE CLEARLY WARNS TO "SNAP LID TO CANISTER BY PRESSING DOWN FIRMLY". IFU STATES "ATTACH THE PENUMBRA ASPIRATION TUBING TO THE ASPIRATION PUMP AND TURN ON THE ASPIRATION PUMP (REFER TO THE ASPIRATION PUMP OPERATION MANUAL). ALLOW THE ASPIRATION PUMP TO RUN FOR AT LEAST ONE MINUTE PRIOR TO USE, AND CONFIRM THAT THE ASPIRATION GAUGE READS 20INHG. ENSURE THE VALVE ON THE PENUMBRA ASPIRATION TUBING IS SWITCHED TO THE OFF POSITION." PUMP OPERATION, MAINTENANCE AND SERVICE MANUAL STATES, "CHECK THE DEGREE OF VACUUM BY PINCHING OFF THE PT TUBE. THE AMOUNT OF VACUUM, IN INCHES OF MERCURY, WILL REGISTER ON THE VACUUM GAUGE. TO INCREASE THE VACUUM, TURN THE REGULATOR NEEDLE CLOCKWISE. TO DECREASE THE VACUUM, TURN THE REGULATOR NEEDLE ANTICLOCKWISE.

    Description of Event or Problem · 1

    PT PRESENTED WITH A BASILAR ARTERY OCCLUSION. PHYSICIAN DELIVERED THE REPERFUSION CATHETER AND BEGAN SEPARATOR ACTION WITH THE ASPIRATION PUMP IN THE "ON" POSITION. AFTER A COUPLE OF MINUTES OF NOT SEEING ANY BLOOD RETURN TO THE PUMP CANNISTER, ASPIRATION WAS CHECKED VIA THE ASPIRATION TUBING AND IT WAS NOTED THAT THE CANNISTER LID WAS NOT COMPLETELY SEALED. UPON THE NEXT CONTRAST INJECTION, THE BASILAR ARTERY WAS NOTED AS OPEN BUT THE CLOT HAD FRACTURED INTO SEVERAL DISTAL/UNREACHABLE ARTERIAL BRANCHES. THE PHYSICIAN REPORTED THAT HE ASSUMED THAT THE SEPARATOR BROKE UP THE CLOT, BUT, BECAUSE OF INCOMPLETE SUCTION THROUGH THE REPERFUSION CATHETER, THE RESTORED BLOOD FLOW CARRIED EMBOLI DISTALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP CANISTER WITH LID CANISTER WITH LID KDQ PENUMBRA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death