BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRESCENT RA 13 FR

    MDR report key: 19168442 · Received April 23, 2024

    Report

    Report Number
    3011468686-2024-00012
    Event Type
    Death
    Date Received
    April 23, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 23, 2024
    Manufacturer
    MEDTRONIC DEXTER (MC3 INC.)
    Product Code
    PZS
    UDI-DI
    10850007732209
    PMA / PMN Number
    K203409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED CRACK IN THE CATHETER IS UNKNOWN. BASED ON THE USER'S DESCRIPTION, ONE POSSIBLE CAUSE OF THE CRACK IS SUTURING TO THE CATHETER BODY. THERE ARE DESIGNATED SUTURE SITES ON THE CATHETER; HOWEVER, IF THE USER APPLIES SUTURES TO THE WIRE REINFORCED REGION OF THE CATHETER BODY, IT IS POSSIBLE TO DAMAGE THE CATHETER.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A FEMALE NEWBORN (36 HOURS OLD, WEIGHT 3.4 KG), 38 WEEK DELIVERY WITH MECONIUM ASPIRATION, WAS CANNULATED WITH A CRESCENT RA 13 FR CATHETER TO THE IJ USING AN OPEN CUT-DOWN TECHNIQUE. THE PATIENT WAS PARALYZED AND SEDATED. APPROXIMATELY 5 MINUTES AFTER ECMO WAS INITIATED, A CRACK WAS NOTICED JUST BELOW THE GOLD SUTURE RING CAUSING AIR ENTRAINMENT AND THE INABILITY TO FLOW THROUGH THE ECMO CIRCUIT. SUTURES WERE PRESENT ON THE CANNULA BODY. IT WAS REPORTED THAT A NEW CATHETER WAS UNABLE TO BE PLACED DUE TO THE SURGEON BEING UNABLE TO PUSH A SECOND CATHETER PAST 4 CM SUCH THAT THE ECMO THERAPY WAS NOT CONTINUED. THE PATIENT WAS REPORTED AS DECEASED. DATE OF DEATH IS (B)(6) 2024. CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947167 CRESCENT RA 13 FR DUAL LUMEN ECMO CATHETER PZS MEDTRONIC DEXTER (MC3 INC.) 70413 2210156 10850007732209

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female Death