BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRESCENT RA 15 FR

    MDR report key: 15817278 · Received November 17, 2022

    Report

    Report Number
    3011468686-2022-00018
    Event Type
    Death
    Date Received
    November 17, 2022
    Report Date
    November 17, 2022
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K203409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS NOT RETURNED FOR ANALYSIS. THERE DOES NOT APPEAR TO BE A DEVICE FAILURE, NOR HAS THE HOSPITAL ALLEGED A DEVICE DEFICIENCY OF THE CRESCENT RA CATHETER. DEFINITIVE ROOT CAUSE OF THE INJURY AND/OR PATIENT DEATH IS NOT FULLY DESCRIBED. REVIEW OF THE INFORMATION PROVIDED BY THE HOSPITAL AND THE ECMO DIRECTOR SUGGESTS THAT THE PLACEMENT LOCATION, POSSIBLY TOO DEEP WITHIN THE ATRIUM, MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE PERFORATION INJURY. THE HOSPITAL HAS REQUESTED FURTHER TRAINING OF THEIR STAFF.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE, A 4-YEAR-OLD FEMALE PATIENT WAS UNDERGOING VV-ECMO WITH A CRESCENT RA CATHETER AND THEN EXPERIENCED AN RA PERFORATION. THIS OCCURRED AFTER A BOWEL MOVEMENT THAT MAY HAVE MOVED THE CATHETER FROM ITS ORIGINAL POSITION IN THE PATIENT'S ANATOMY. THE CLINICAL ACTIONS WERE "CHEST TUBE, VA". ON (B)(6) 2022, THE ECMO DIRECTOR DESCRIBED THAT THE CATHETER WAS LIKELY PLACED TOO DEEP INITIALLY. THE PATIENT EXPIRED, AND MINIMAL DETAILS OF THIS CASE WERE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2839080 CRESCENT RA 15 FR DUAL LUMEN ECMO CATHETER PZS MC3 INC. 70415

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Death