BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 CRESCENT

    MDR report key: 10504396 · Received September 8, 2020

    Report

    Report Number
    3011468686-2020-00004
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 4, 2020
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K180151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR RECEIVED INFORMATION THAT DURING CANNULA INSERTION OF THE MC3 70130 CRESCENT JUGULAR CATHETER USING A SUBCLAVIAN APPROACH, THE CUSTOMER NOTICED A KINK AT THE JUNCTION BENEATH THE CLAVICLE A FEW DAYS AFTER INSERTION; DURING THIS SPECIFIC INSTANCE THEY ALSO NOTICED CLOTS WITHIN THE CANNULA (MODEL NUMBER 70130). THE DEVICE WAS NOT RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. NO ADVERSE PATIENT EFFECTS OCCURRED. THE CUSTOMER STATED THAT THEY PREFER TO USE A SUB-CLAVIAN INSERTION FOR THE CRESCENT CATHETER AND THEY ORIGINALLY THOUGHT IT WAS KINKED. HOWEVER WHEN THEY REMOVED THE CANNULA AFTER THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) RUN THEY REALIZED THERE WAS A CLOT. THE CAUSE OF BLOOD CLOT IS UNKNOWN. THE LOCATION OF THE BLOOD CLOT IS AT THE DISTAL DRAINAGE HOLES OF THE CATHETER, POSITIONED WITHIN THE INFERIOR VENA CAVA WHICH DRAWS BLOOD INTO THE EXTRACORPOREAL CIRCUIT. THE KINK IS LOCATED AT THE PROXIMAL END OF THE CATHETER, LOCATED OUTSIDE OF THE BODY. CATHETER KINKS MAY RESULT IN REDUCED BLOOD FLOW CONDITIONS, HOWEVER THE CLINICIAN DID NOT MENTION INADEQUATE PERFUSION. ADDITIONALLY THE BLOOD CLOT POSITIONED AT THE DISTAL/DRAINAGE END OF THE CATHETER DOES NOT SUPPORT THE KINK BEING THE CAUSE OF THE BLOOD CLOT BECAUSE OF THE DIRECTION OF FLOW. IN THIS SCENARIO, THE CLOT IS UPSTREAM FROM THE KINK. IF THE KINK CAUSED THE BLOOD CLOT, THE OXYGENATOR OR OTHER ANCILLARY CIRCUIT COMPONENTS WOULD BE THE MOST LIKELY LOCATION OF THE CLOT. THE MOST LIKELY CAUSE OF THE KINK IS THE SUB-CLAVIAN INSERTION METHOD. MC3 DOES NOT RECOMMEND THE USE OF SUB-CLAVIAN INSERTION METHOD FOR CRESCENT CATHETERS AND THE IFU WARNS THE CATHETER MAY NEED TO BE REPLACED IF A KINK DEVELOPS. THE KINK WAS LIKELY CAUSED BY THE EXTREME BEND OF THE CATHETER DUE TO THE SUB-CLAVIAN INSERTION METHOD AND/OR PATIENT MOVEMENT.

    Description of Event or Problem · 1

    DISTRIBUTOR RECEIVED INFORMATION THAT DURING CANNULA INSERTION OF THE MC3 70130 CRESCENT JUGULAR CATHETER USING A SUBCLAVIAN APPROACH, THE CUSTOMER NOTICED A KINK AT THE JUNCTION BENEATH THE CLAVICLE A FEW DAYS AFTER INSERTION; THE CUSTOMER STATED THAT THEY PREFER TO USE A SUB-CLAVIAN INSERTION FOR THE CRESCENT CANNULA AND THEY ORIGINALLY THOUGHT THE CANNULA WAS KINKED. HOWEVER WHEN THEY REMOVED THE CANNULA AFTER THE EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) RUN THEY REALIZED THERE WAS A CLOT. THERE HAVE BEEN ADDITIONAL INSTANCES OF KINKS WHEN USING CANNULA SIZES 28 - 32FR USING A SUBCLAVIAN APPROACH. THE EXACT DATES, PART NUMBERS AND LOT NUMBERS ARE UNKNOWN FOR THESE OCCURRENCES. THERE ARE NO CANNULA DEVICES TO RETURN AS THEY WERE DISCARDED BY THE CUSTOMER. NO ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THESE OCCURRENCES. IT WAS REPORTED THAT THIS IS HAPPENING ON ANY OF THE SIZES THEY USE 28-32FR WITH THIS INSERTION METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970168 MC3 CRESCENT DUAL LUMEN ECMO CATHETER PZS MC3 INC. 70130

    Patients

    Seq Age Sex Outcome Treatment
    1