BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRESCENT RA 15 FR

    MDR report key: 14897547 · Received July 2, 2022

    Report

    Report Number
    3011468686-2022-00012
    Event Type
    Death
    Date Received
    July 2, 2022
    Date of Event
    February 27, 2022
    Report Date
    July 2, 2022
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K203409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 WAS AN ALLEGED DEVICE DEFICIENCY OF THE CRESCENT RA CATHETER SPECIFICALLY DESCRIBED. MC3 IS COMMITTED TO PROVIDING INFORMATION TO SURGEONS AND ECMO SPECIALISTS AS WE LEARN MORE ABOUT DIFFICULT SURGICAL CHALLENGES ENCOUNTERED IN THE PLACEMENT OF THE CATHETERS AND WITH THE MANAGEMENT OF PATIENTS DURING VV-ECMO.

    Description of Event or Problem · 0

    CRESCENT RA CATHETER 15 FR WAS PLACED INTO RIJ OF A 20 MONTH OLD FEMALE PATIENT USING THE CUT-DOWN APPROACH. IMAGING USED WAS ECHOCARDIOGRAPHIC GUIDANCE. PERICARDIAL EFFUSION IS ASSUMED TO HAVE OCCURRED WITHIN THE FIRST 36-48 HOURS ON ECMO AND TAMPONADE OCCURRED SLOWLY. THE CAUSE OF TAMPONADE IN THIS PATIENT IS NOT CLEAR. PATIENT ARRESTED AND CHEST COMPRESSIONS WERE STARTED. SHE ARRESTED AGAIN. STARTED CHEST COMPRESSION AGAIN. DRAIN WAS PLACED. THERE WAS SIGNIFICANT BLEEDING AND THEN THE PATIENT DEATH OCCURRED (B)(6) 2022. AUTOPSY REVEALED A RIGHT VENTRICULAR TEAR. THERE WERE NO SIGNS OF INJURIES FOUND IN THE RA. THE RV TEAR THAT MAY HAVE OCCURRED WITH CATHETER IN PLACE DURING CPR. THIS EVENT WAS ALSO REPORTED BY THE HOSPITAL WITH CORRESPONDING MEDWATCH REPORT: (B)(4). PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIAL DRAIN PLACED. THIS PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT AND WAS CANNULATED WITH A MC3 CRESCENT RA DUAL LUMEN CATHETER 15FR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548945 CRESCENT RA 15 FR DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70415

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Female Other| D