BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEM-FLEX II FEMORAL ARTERIAL CANNULA

    MDR report key: 2851262 · Received November 26, 2012

    Report

    Report Number
    2851262
    Event Type
    Death
    Date Received
    November 26, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 26, 2012
    Manufacturer
    EDWARDS LIFESCIENCES CORP
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE PT WAS SCHEDULED AND PREPPED FOR A LIVER TRANSPLANT. THE PT WAS TO BE PLACED ON VENOVENOUS BYPASS. DURING PLACEMENT OF THE PERFUSION CANNULA IN THE RIGHT INTERNAL JUGULAR VEIN, CANNULA WAS ADVANCED OVER WIRE WITHOUT RESISTANCE. UPON REMOVAL OF GUIDEWIRE, OBSERVED SPRING OVER GUIDEWIRE UNRAVELED FROM WIRE. WHEN BYPASS WAS INITIATED, THE PT BECAME SEVERELY HYPOTENSIVE WITH SUBSEQUENT CARDIAC ARREST. IT WAS LATER DISCOVERED THAT THE PT HAD INJURY TO THE SUPERIOR VENA CAVA. THE PT LATER EXPIRED THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEM-FLEX II FEMORAL ARTERIAL CANNULA 16 FR PERFUSION CANNULA DWF EDWARDS LIFESCIENCES CORP 59304339

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death