BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT RA 19 FR

    MDR report key: 17280172 · Received July 7, 2023

    Report

    Report Number
    3011468686-2023-00009
    Event Type
    Injury
    Date Received
    July 7, 2023
    Report Date
    July 6, 2023
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K203409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THERE WAS NO DEVICE PROBLEM ALLEGED. IT WAS REPORTED THE CATHETER WAS DISCARDED AFTER USE. MANUFACTURER DOES NOT HAVE SUFFICIENT INFORMATION AT THIS TIME TO ESTABLISH A CAUSE OF INJURY.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE, A 2 YEAR OLD, 15KG, WAS CANNULATED WITH A CRESCENT RA 19FR CATHETER FOR VV ECMO SUPPORT STATUS POST PEANUT ASPIRATION. CATHETER PLACEMENT WAS UNEVENTFUL USING FLUOROSCOPY AND DESIRED VV ECMO FLOWS WERE ACHIEVED. POSTOPERATIVE X-RAY IMAGES IMPLIED THE CATHETER POSITION WAS IN THE BODY OF THE RIGHT ATRIUM. AFTER APPROXIMATELY 24 HOURS OF ECMO SUPPORT, THE DECISION WAS MADE TO DECANNULATE AND REMOVE THE PATIENT FROM ECMO SUPPORT AS THE PATIENT'S PULMONARY CONDITION HAD IMPROVED. JUST PRIOR TO DECANNULATION, THE PATIENT BEGAN COUGHING WITH INTENSITY AND ECMO FLOW WAS IMPACTED. BEDSIDE ULTRASOUND CONFIRMED BLOOD IN THE PERICARDIAL SPACE. ECMO FLOW WAS STOPPED AS THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE LEADING TO CARDIAC ARREST. THE PATIENT'S CHEST WAS OPENED AND TRANSTHORACIC CANNULATION WAS ACCOMPLISHED INCLUDING REPAIR OF A RIGHT ATRIAL PERFORATION. SIGNIFICANT BLOOD LOSS OCCURRED AND THE PATIENT WAS PLACED ON VA ECMO SUPPORT. CARDIAC STATUS RECOVERED. THE PATIENT EXPERIENCED A NEUROLOGIC DEFICIT AND WAS DISCHARGED TO A REHABILITATION FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039829 CRESCENT RA 19 FR DUAL LUMEN ECMO CATHETER PZS MC3 INC. 70419

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Unknown Required Intervention