BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN REINFORCED DUAL LUMEN CATHETER

    MDR report key: 8472105 · Received April 2, 2019

    Report

    Report Number
    1646848-2019-00007
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Report Date
    April 1, 2019
    Manufacturer
    ORIGEN BIOMEDICAL, INC
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Removal / Correction Number
    Z-0180-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    PER PREVIOUS INVESTIGATION ON SIMILAR EVENT, IT WAS DISCOVERED THAT THE VENDOR PRODUCED CERTAIN CATHETER SIZES WITH A GRADE OF PEBAX THAT DOES NOT CONTAIN BASO4. NATIVE PEBAX IS MILDLY RADIOPAQUE, AND THE WIRE REINFORCEMENT IS FAIRLY DENSE AND VERY RADIOPAQUE. WITHOUT BASO4 IN THE EXTUSIONS, THE LAST FEW CM OF THE CATHETER TIP ARE HARDER TO VISUALIZE ON X-RAY. WHEN 20% BASO4 IS ADDED, PEBAX BECOMES MODERATELY RADIOPAQUE. X-RAYS OF RDLC WITH AND WITHOUT BASO4 WERE TAKEN AND SHOWN IN (B)(4). BOTH VERSIONS WITH AND WITHOUT BASO4 CAN BE SEEN ON X-RAY, AND BOTH ARE CONSIDERED RADIOPAQUE, ALTHOUGH TO DIFFERENT DEGREES. WHILE RADIOGRAPHY IS A USEFUL AID, THE IFU (LC08, R05) INSTRUCTS THE USER THAT, "RECIRCULATION CAN BE MINIMIZED BY ORIENTING THE CATHETER WITH THE RE-INFUSION PORT POINTED AT THE TRICUSPID VALVE. THIS SHOULD BE CONFIRMED WITH COLOR DOPPLER ECHO." THE USE OF ULTRASOUND FOR PLACEMENT IS MUCH MORE ACCURATE, ALLOWS FOR DEPTH AND ROTATIONAL PLACEMENT OPTIMIZATION AND ULTRASOUND SYSTEMS ARE MUCH MORE WIDELY AVAILABLE THAN X-RAY SYSTEMS. WHILE THE RADIOPACITY OF THE ORIGEN CATHETER COULD BE IMPROVED, AND IT WAS INTENDED TO HAVE BASO4 IN THE EXTRUSIONS, IT IS A VERY SELDOM USED FEATURE. ADDITIONALLY, THERE ARE OTHER, BETTER METHODS AVAILABLE AND RECOMMENDED TO POSITION THE CATHETER. ALSO, WHILE THE CATHETER CAN BE SEEN ON X-RAY, IT IS JUDGED MORE CHALLENGING, AND BASO4 SHOULD BE USED IN FUTURE PRODUCTS. FINALLY, USE OF X-RAY TO POSITION THE CATHETER SEEMS TO BE USED BY A VERY SMALL FRACTION OF USERS.

    Description of Event or Problem · 1

    CUSTOMER HAD TROUBLE BEING ABLE TO LOCATE THE TIP FO THE CANNULA (19F), ESPECIALLY WITH A WHITE OUT X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269559 ORIGEN REINFORCED DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC VV19F N18394

    Patients

    Seq Age Sex Outcome Treatment
    1