BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRESCENT RA 13 FR

    MDR report key: 14918542 · Received July 5, 2022

    Report

    Report Number
    3011468686-2022-00015
    Event Type
    Death
    Date Received
    July 5, 2022
    Date of Event
    May 28, 2022
    Report Date
    July 5, 2022
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K203409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. 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

    THE FOLLOWING EVENT WAS DESCRIBED TO THE DISTRIBUTER. "A 4 MONTH OLD MALE PATIENT WAS CANNULATED WITH 13 FR CRESCENT RA. PATIENTS ANATOMY AND DIAPHRAGM WAS INVERTED VERY LOW. CATHETER WAS PLACED VIA X-RAY AND CONFIRMED VIA ECHO POST INITIAL PLACEMENT TWICE. CARDIOLOGIST CONFIRMED PLACEMENT WAS CORRECTLY IN RIGHT ATRIUM PER IFU, ALTHOUGH A LITTLE LOW IN THE ATRIUM. THE CANNULA IS NOT THOUGHT TO BE THE ISSUE. THE PATIENTS CONDITION IS THOUGHT TO BE THE ISSUE. CANNULA FLOW WAS FINE PER DOCTOR AND PLACEMENT WAS CONFIRMED TO BE CORRECT. DOCTOR WHO PLACED CANNULA WAS TRAINED AS WELL AS ENTIRE STAFF. ONLY THEORY MENTIONED: AS THE RES SETTING ROSE, THE DIAPHRAGM AND HEART ALWAYS ROSE WHICH INVERSELY MEANT THAT THE CANNULA MAY HAVE LOWERED. PATIENT DEATH IS POSTED AS PERFORATION OF IVC." FOUR OTHER CATHETERS FROM THIS SAME LOT NUMBER HAD NO COMPLICATIONS. THESE 5 CATHETERS WERE USED ON THE ONLY 5 CASES AT HOSPITAL THUS FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450151 CRESCENT RA 13 FR DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70413

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male Death