BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGEN REINFORCED DUAL LUMEN CATHETER

    MDR report key: 8415474 · Received March 13, 2019

    Report

    Report Number
    1646848-2019-00004
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    April 7, 2017
    Report Date
    January 10, 2019
    Manufacturer
    ORIGEN BIOMEDICAL, INC
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO ORIGEN FOR EVALUATION SO DEFINITIVE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. DISCUSSION WITH THE SURGEON REVEALED PROBABLE CANNULATION ERROR WITH CATHETER PLACED TOO LOW. SURGEON CONFIRMED THAT PERFORATION OCCURRED DURING GUIDEWIRE PLACEMENT BEFORE THE CATHETER WAS INTRODUCED.

    Description of Event or Problem · 1

    A (B)(6) MONTH OLD PATIENT WAS CANNULATED ON VV ECLS ON (B)(6) 2017 VIA A 13 FRENCH ORIGEN CANNULA IN THE RIGHT INTERNAL JUGULAR VEIN. THE RUN WENT EXTREMELY WELL AND THE PATIENT WAS GETTING READY TO BE DECANNULATED ON (B)(6) 2017. IN PREPARATION FOR DECANNULATION, A GEL PILLOW WAS REMOVED FROM BEHIND THE PATIENT'S HEAD AND THE CHIN MOVED FORWARD. THE PATIENT WENT ASYSTOLIC AND THE FLOW WENT DOWN TO 0 ON THE CARDIOHELP. AFTER A FEW SECONDS, IT BECAME APPARENT THAT THERE WAS A PERFORATION IN THE HEART AND THE PATIENT WAS IN CARDIAC ARREST. THE PATIENT WAS CODED AND CANNULATED VIA V-A. AFTER THE PATIENT WAS STABILIZED, THE PEDIATRIC SURGEON LOOKED AT THE OLD 13 FRENCH ORIGEN CANNULA AND NOTED THAT IT SEEMED EXTREMELY STIFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209627 ORIGEN REINFORCED DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC VV13F M18182

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Life Threatening| R