BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL ARTERIAL CATHETER

    MDR report key: 2491859 · Received March 14, 2012

    Report

    Report Number
    3008500478-2012-00211
    Event Type
    Death
    Date Received
    March 14, 2012
    Date of Event
    February 27, 2012
    Report Date
    April 20, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K891576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED UPON ARRIVAL OF PRODUCT. DUE TO DIFFICULTY IN PLACEMENT AND SECURING OF THIS DEVICE WHEN SWITCHED TO A JUGULAR PLACEMENT (OFF-LABEL USE); IT APPEARS TO BE TORN FROM METHODS OF SECURING THE DEVICE. AT THIS TIME IT APPEARS TO BE USE ERROR, NOT A MANUFACTURING DEFECT BUT INVESTIGATION WILL CONTINUE INTO THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE CANNULA WAS EVALUATED BY QUALITY ENGINEERING AND MANUFACTURING ENGINEERING. THE CUSTOMER REPORT OF A "TEAR" IN THE PROXIMAL SECTION OF THE CANNULA WAS CONFIRMED. A TEAR APPROXIMATELY 0.2" WIDE, WAS FOUND AT THE WIRE WOUND TO OVER MOLD SECTION. WIRE WAS EXPOSED AT THE TEAR. THE WIRE WOUND SECTION OF THE CANNULA BODY WAS ALSO PINCHED 3/4" DISTAL FROM THE TEAR AND A SECOND PINCH WAS LOCATED 1 AND 1/4" DISTAL FROM THE TEAR. GREEN COLORED SUTURE THREAD WAS WRAPPED AROUND THE SUTURE RING. A REVIEW OF MANUFACTURING RECORDS WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. THE ROOT CAUSE OF THE TEAR FOUND AT THE JUNCTION OF THE WIRE WOUND CANNULA BODY AND OVER MOLD COULD NOT BE DETERMINED. IT IS THEORIZED THAT THE TEAR WAS THE RESULT OF AN ACCIDENTAL PERFORATION BY A SCALPEL. THE EXPOSED WIRE WAS THE EFFECT OF THE TEAR. THE SALES REP SPOKE TO THE PERFUSIONIST. THE CANNULA WAS SECURED AT THE NECK WITH A SUTURE. THIS SUTURE WAS FIXED/KNOTTED NOT DIRECTLY WITH THE CANNULA BUT WITH THE FLEXIBLE PART OF THE CANNULA. THIS CANNULA WAS USED IN AN OFF-LABEL APPROACH, DUE TO THE LENGTH OF THIS CANNULA, A SCALPEL IS WAS USED TO EXTEND THE INCISION. IN THIS WAY IT COULD HAPPEN THAT THE CANNULA WAS PERFORATED ACCIDENTALLY. THE SURGEON DISASSOCIATES THE DEVICE FROM THE DEATH. THE CAUSE OF DEATH WAS FULMINANT CARDIOPULMONARY DECOMPENSATION WITH HYPOXIC RESPIRATORY INSUFFICIENCY WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    AS REPORTED BY PHONE, THE FEMORAL ARTERIAL CANNULA WAS USED IN THE JUGULAR VEIN FOR ECMO AND FOUND TO HAVE A TEAR IN THE CATHETER. THE PATIENT WAS PUT ON ECMO (VENO-ARTERIAL) ON THE (B)(6)-2012 IN THE ICU. ON THE (B)(6)-2012 IT WAS CHANGED TO VENO-VENOUS BECAUSE OF WORSENING LUNG PARAMETERS. AT WHICH POINT THE FEMORAL ARTERIAL CANNULA WAS SWITCHED TO THE JUGULAR VEIN. THIS VENO-VENOUS CANULATING WAS IN PLACE FOR ABOUT 1-1.5 HOURS WITHOUT ANY PROBLEMS. THEN SUDDENLY IT SEEMED THAT THE ECMO SYSTEM PULLED AIR AND THE CANULA WAS PINCHED OFF. IT SEEMED THE CANULA PULLED AIR AS THE TEAR IN THE CANNULA WAS FOUND PROXIMAL TO THE CANNULA. THERE WAS VERY LITTLE BLOOD LOSS. THE ECMO WAS INTERRUPTED. PATIENT LATER DIED UNKNOWN IF DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL ARTERIAL CATHETER ARTERIAL CATHETER DWF EDWARDS LIFESCIENCES DIIFEMII016A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death