BEUDAMED
    FDA Adverse Event Death Summary report: N

    MC3 CRESCENT RA 15 FR

    MDR report key: 14331960 · Received May 7, 2022

    Report

    Report Number
    3011468686-2022-00005
    Event Type
    Death
    Date Received
    May 7, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 6, 2022
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    UDI-DI
    10850007732216
    PMA / PMN Number
    K203409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED. THE OBSTRUCTION OF TISSUE IN THE DRAINAGE LUMEN WAS CONFIRMED, AND IT IS NOTED THAT THIS OBSTRUCTION WOULD HAVE REDUCED THE FLOW THROUGH THE CATHETER. EVIDENCE OF A KINK WAS FOUND WHERE SUTURES WERE TIED DIRECTLY TO THE CATHETER BODY, WHICH MAY OR MAY NOT HAVE RESTRICTED FLOW. THE CAUSE OF RECIRCULATION WAS NOT IDENTIFIED. THE REASON FOR HAND CRANKING THE PUMP WAS NOT DESCRIBED. THE CUSTOMER STATED THAT A .025-INCH GUIDEWIRE WAS NOT AVAILABLE AND THAT THE 15 FR CRESCENT CATHETER WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN PERCUTANEOUSLY. THE 15 FR CRESCENT RA IS DESIGNED FOR A .025-INCH GUIDEWIRE WHEN PLACED PERCUTANEOUSLY. DEVICE HISTORY RECORDS INDICATE THAT THE DEVICE MET SPECIFICATION AND NO ANOMALY WAS IDENTIFIED RELATING TO THE DEVICE MANUFACTURING.

    Description of Event or Problem · 0

    MC3 RECEIVED INFORMATION ON (B)(6) 2022 THAT DURING USE OF A 15 FR MC3 CRESCENT CATHETER AND A 15FR BIO-MEDICUS CANNULA AN ADVERSE EVENT OCCURRED ON (B)(6) 2022 DURING AN UNSUCCESSFUL ATTEMPT TO INITIATE ADEQUATE CARDIOPULMONARY SUPPORT. THE CUSTOMER REPORTED THAT THE 15 FR CRESCENT CATHETER WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN (RIJV) PERCUTANEOUSLY. NO FLUOROSCOPY WAS USED FOR CANNULATION, INSTEAD AN ECHOCARDIOGRAM WAS PERFORMED AT THE BEDSIDE. THE CIRCUIT WAS ATTACHED TO THE CATHETERS AND RPMS INCREASED TO 2000, AND LPMS COULD NOT INCREASE HIGHER THAN 350(ML/MIN). THE CUSTOMER REPORTED THAT THE VENOUS RETURNS WERE POSITIVE, AND THE MEMBRANE PRESSURES WERE IN THE 90'S. THE SURGEON MANIPULATED THE CATHETER WITH NO CHANGE, ECHOCARDIOGRAM WAS PERFORMED AT BEDSIDE. SURGEON ADDED A 15FR BIO-MEDICUS CANNULA AND Y'D IN WITH THE MC3 CRESCENT CATHETER, THEY WERE STILL NOT ABLE TO GET FLOW. THE SVO2 REMAINED IN 90'S, ALERTING THE CUSTOMER THAT THEY WERE JUST RECIRCULATING. THE CUSTOMER STATED THAT BOTH CATHETERS WHEN UNCLAMPED HAD GREAT BLOOD RETURN AND WERE ABLE TO FLUSH. THE PATIENT BEGAN TO CODE ONCE THEY WERE UNABLE TO FLOW ADEQUATELY ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE CUSTOMER STARTED COMPRESSIONS AND MEDICATIONS WERE GIVEN. THE CARDIOHELP DISPOSABLE WAS REMOVED FROM THE CENTRIFUGAL HEAD AND PLACED ON THE HAND CRANK. THEY HAND CRANKED TO TRY TO GET FLOW WITH DIFFICULTY. THE PEDIATRIC ICU TEAM CALLED THE CODE. THE CUSTOMER EXAMINED BOTH CATHETERS FOR CLOTS OR OBSTRUCTIONS. A PIECE OF WHAT APPEARED TO BE TISSUE WAS REMOVED FROM A FEW HOLES ON THE CATHETER. NO CLOTS OR OTHER OBSTRUCTIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353425 MC3 CRESCENT RA 15 FR DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70415 2108112 10850007732216

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death