BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN REINFORCED DUAL LUMEN CATHETER

    MDR report key: 8472106 · Received April 2, 2019

    Report

    Report Number
    1646848-2019-00006
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Report Date
    March 31, 2019
    Manufacturer
    ORIGEN BIOMEDICAL, INC
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE CATHETER WAS EXAMINED AND IT WAS CONFIRMED THAT THERE WAS A CRACK AT THE JUNCTION OF THE REFLOW LAYER. CLOSE EXAMINATION DID NOT REVEAL ANYTHING THAT LOOKED LIKE CUT MARKS. IT WAS POSSIBLE TO SEE THE WIRE REINFORCING LAYER AT THE BOTTOM OF THIS CRACK. THE PRODUCT WAS SENT BACK TO THE SUPPLIER WHO MADE THE TIP, BUT THEY WERE NOT ABLE TO DEDUCE A CAUSE. THE FAILURE MODE WAS ABLE TO BE REPRODUCED ONLY WHEN PULLING ON THE TIP OF THE CATHETER WITH A PULL FORCE OF ABOUT 15KG, WHICH IS MUCH MORE THAN EXPECTED DURING ROUTINE DECANNULATION. THE WIRE EXPOSURE WAS AT THE BOTTOM OF THE CRACK AND DID NOT PENETRATE THROUGH THE FLOW CHANNELS, SO THERE WOULD HAVE BEEN NO COMMUNICATION WITH THE BLOOD PATH OR CONTACT WITH THE SKIN. BASED ON INVESTIGATION AND BATCH RECORD REVIEW, A ROOT CAUSE CANNOT BE IDENTIFIED. THE MOST PROBABLE CAUSE IS EXTREME STRETCHING/PULLING IN THE FIELD (LIKELY SOMEONE PULLED ON THE TIP AND CLEAR TUBES TO CHECK BONDING).

    Description of Event or Problem · 1

    A VV16F ORIGEN DUAL LUMEN ECMO CATHETER, LOT N18446 WAS USED DURING AN ECMO PROCEDURE. AFTER INSERTION OF THE CANNULA AND WHILST THE PATIENT WAS SUPPORTED ON ECMO, THE SURGEON NOTICED A SLIT CUT TO THE OUTER COATING OF THE CANNULA AND COULD SEE THE REINFORCED WIRE PART OF THE CANNULA. THIS PORTION WAS OUTSIDE OF THE BODY AND AN ASSESSMENT WAS MADE TO LEAVE THE CANNULA IN-SITU RATHER THAN RECANNULATE THE PATIENT WHICH MAY HAVE CAUSED SIGNIFICANT HAEMODYNAMIC INSTABILITY. THE PATIENT WAS SUPPORTED ON ECMO FOR 9 DAYS WITHOUT ANY ISSUES. IT APPEARS THAT THERE MAY HAVE BEEN A FAILURE OF THE BONDING WHERE IT MEETS THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269592 ORIGEN REINFORCED DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC VV16F N18446

    Patients

    Seq Age Sex Outcome Treatment
    1