BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL ARTERIAL CANNULAE

    MDR report key: 2880499 · Received December 19, 2012

    Report

    Report Number
    3008500478-2012-00344
    Event Type
    Death
    Date Received
    December 19, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 4, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K891576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL REPORTED UF NUMBER AS (B)(4). DEVICE WAS NOT RETAINED FOR EVALUATION INTO ROOT CAUSE. THIS DEVICE WAS USED OFF INDICATION FOR USE. THIS IS A FEMORAL CANNULAE THAT WAS USED BY THE FACILITY IN THE JUGULAR FOR VENO VENOUS BYPASS FOR A LIVER TRANSPLANT. THE PRODUCT WAS NOT RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THEREFORE A CAPA WILL NOT BE INITIATED FOR THIS EVENT. THIS INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDWATCH ((B)(4)) THAT "(B)(6) MALE WAS SCHEDULED AND PREPPED FOR A LIVER TRANSPLANT,. THE PATIENT WAS TO BE PLACED ON VENOVENOUS BYPASS. DURING PLACEMENT OF THE PERFUSION CANNULA IN THE RIGHT INTERNAL JUGULAR VEIN, THE CANNULA WAS ADVANCED OVER WIRE WITHOUT RESISTANCE. UPON REMOVAL OF GUIDEWIRE, OBSERVED SPRING OVER GUIDEWIRE UNRAVELED FROM WIRE. WHEN BYPASS WAS INITIATED THE PATIENT BECAME SEVERELY HYPOTENSIVE WITH SUBSEQUENT CARDIAC ARREST. IT WAS LATER DISCOVERED THAT THE PATIENT HAD INJURY TO THE SUPERIOR VENA CAVA. THE PATIENT LATER EXPIRED THAT EVENING." ADDITIONAL INFORMATION GATHERED FROM HOSPITAL, THAT THE GUIDEWIRE HAD TRACKED INTO THE PATIENT'S "THORACIC CAVITY"; SUBSEQUENTLY CAUSING THE CATHETER TO FOLLOW THE GUIDEWIRE, THIS WAS NOT NOTED UNTIL THE INITIATION OF BYPASS. THE PATIENT'S INJURY WAS A TEAR OF THE SUPERIOR VENA CAVA THAT WAS FOUND UPON THE SURGEON OPENING THE PATIENT'S CHEST CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL ARTERIAL CANNULAE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES DIIFEMII016A 59304339

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death