BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTECH REMOTE ACCESS PERFUSION CANNULA NB21FR

    MDR report key: 930162 · Received October 19, 2007

    Report

    Report Number
    2953686-2007-00001
    Event Type
    Malfunction
    Date Received
    October 19, 2007
    Date of Event
    March 30, 2007
    Report Date
    March 30, 2007
    Manufacturer
    ESTECH
    Product Code
    DWF
    PMA / PMN Number
    K990573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ESTECH EXAMINED 12 UNITS OF 103-400 LOT NUMBER 60842394, THE SAME LOT OF THE REPORTED INCIDENT. THIS LOT HAD BEEN PREVIOUSLY TESTED TO 100% FOR CONCERNS OF LEAK PATHWAYS AS DESCRIBED ABOVE, AS INDICATED BY OBSERVED SCORE MARKS FROM THE MANIFOLD MOLDED TOOLING ON THE 3/8' TUBE. WE VISUALLY SELECTED THE WORST CASE PRODUCT EXHIBITING TOOLING SCORES IN THE 3/8" TUBING, THE AREA AIR BUBBLES HAD BEEN DETECTED IN THE REPORTED EVENT. A SIMULATED FLOW CIRCUIT WAS CREATED TO BOTH BACK FLOW BLOOD INTO THE CANNULA, SIMULATING CLINICAL INSERTION OF THE CANNULA, AND FRONT FLOW BLOOD SIMULATING TYPICAL USE WHEN CONNECTED TO THE CPB CIRCUIT. THEN CANNULA WAS PRESSURIZED UP TO 548MMHG, FAR EXCEEDED TYPICAL CLINICAL PRESSURES. NO LEAKS FOR UNUSUAL AIR BUBBLE PHENOMENA WERE DETECTED. THE DEVICE IN QUESTION WAS EXAMINED. THE FAILURE COULD NOT BE REPLICATED. HOWEVER PRESENCE OF A LEAK WAS OBSERVED IN THE 3-LUMEN TUBING. IT IS HYPOTHESIZED THAT THIS DEVICE FAILURE COMBINED WITH USER ERROR OF CLAMPING THE 3 LUMEN TUBE AT A LOCATION DISTAL TO THE LEAK, COMBINED WITH USE OF A CENTRIFUGAL PUMP AT LOW RPM PRIOR TO BEGINNING PERFUSION (VS A PERISTALTIC PUMP) THEORETICALLY COULD HAVE ALLOWED FOR INTRODUCTION OF AIR BUBBLES.

    Description of Event or Problem · 1

    DURING THE AORTIC ARCH CONDUIT GRAFT SURGICAL PROCEDURE ESTECH RAP ARTERIAL 21 FR NB CANNULA WAS PUT IN LEFT FEMORAL ARTERY BY THE SURGEON USING THE CUTDOWN METHOD PER THE USUAL PROCEDURE. THE CANNULA WAS INSERTED EASILY INTO MALE PATIENT. THE CANNULA WAS "DE-AIRED" USING THE BLEED BACK METHOD AND FILLING THE CANNULA, AND THEN THE ADDITIONAL PRESSURE LINE WITH STOPCOCK WAS DONE IN THE SAME MANNER. IN ORDER TO CONTINUE THE PROCESS THE SURGEON TAPPED THE CANNULA TO ENCOURAGE THE MICRO BUBBLES TO RISE TO THE SURFACE FOR THE DE-AIRING PROCESS. AIR WAS NOTICE EXITING FROM THE WHITE HOUSING COMPONENT WHILE THE CANNULA WAS STITCHED DOWN THE PATIENT'S LEG. AFTER THE RAP FEMORAL VENOUS WAS INSERTED IN THE ADJACENT GROIN, BEFORE THE PATIENT WAS PUT ON BYPASS, ADDITIONAL AMOUNTS OF AIR WAS SEEN IN THE RAP ARTERIAL LINE UNDERNEATH WHERE THE BLOOD WAS FLOWING BACK SLIGHTLY FROM THE ARTERY INTO THE CANNULA BEFORE COMMENSING BYPASS. THE SURGEON OPTED TO REMOVE THE ESTECH CANNULA, AND USED A DIFFERENT ARTERIAL CANNULA TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTECH REMOTE ACCESS PERFUSION CANNULA NB21FR RAP CANNULA NB 21 FR DWF ESTECH 103-400 20842394

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention