BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MC3

    MDR report key: 22703529 · Received August 4, 2025

    Report

    Report Number
    3011468686-2025-00057
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    June 9, 2025
    Report Date
    August 4, 2025
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K180151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. CONTINUATION OF D10: PRODUCT ID 70124, (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0183-CANNULA; IMPLANT DATE N/A; EXPLANT DATE N/A. G2: CITATION: AUTHOR: PHILIP S. BOONSTRA LITERATURE REFERENCE: THE LITERATURE ARTICLE HAS NOT BEEN RELEASED TO THE PUBLIC; THEREFORE, IT HAS NOT BEEN ATTACHED TO THIS REPORT. HOWEVER, WE ARE PROVIDING THE PUBLISHER¿S WEBSITE: HTTPS://WWW.ELSO.ORG/ NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    THIS STUDY ANALYZES DATA FROM THE EXTRACORPOREAL LIFE SUPPORT ORGANIZATION (ELSO) REGISTRY, FOCUSING ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) RUNS INITIATED FOR RESPIRATORY SUPPORT. THE REGISTRY CONTAINS DATA VOLUNTARILY SUBMITTED BY PARTICIPATING CENTERS AND RETROSPECTIVELY COLLECTED FROM PATIENT MEDICAL RECORDS BETWEEN JANUARY 1, 2018, AND APRIL 15, 2025. THE GOAL OF THE ANALYSIS WAS TO EVALUATE ECMO RUNS USING DIFFERENT CANNULA TYPES, STRATIFIED BY PATIENT AGE AND CATHETER CONFIGURATION. THE STUDY POPULATION INCLUDED PATIENTS WHO UNDERWENT A SINGLE ECMO RUN THAT LASTED AT LEAST ONE HOUR, INCLUDED A RECORDED CANNULA ID, AND WAS INITIATED SPECIFICALLY FOR RESPIRATORY SUPPORT. PATIENTS WERE CATEGORIZED BY AGE AT THE START OF ECMO INTO THREE GROUPS: ADULT (OLDER THAN 18 YEARS), PEDIATRIC (29 DAYS TO 18 YEARS), AND NEONATAL (28 DAYS OR YOUNGER). THIS EVENT WAS CREATED TO REPORT RESULTS SPECIFIC TO THE PEDIATRIC POPULATION. THE ADULT AND NEONATAL GROUPS WERE ANALYZED IN SEPARATE EVENTS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: CRESCENT JUGULAR DUAL-LUMEN CATHETER AND CRESCENT RA JUGULAR DUAL-LUMEN CATHETER (PEDIATRIC). AMONG PEDIATRICS, THERE WERE 289 ELIGIBLE RUNS USING THE CRESCENT JUGULAR DUAL-LUMEN CATHETER AND 440 ELIGIBLE RUNS USING THE CRESCENT RA JUGULAR DUAL-LUMEN CATHETER. FOR BOTH CRESCENT JUGULAR DUAL-LUMEN CATHETER AND CRESCENT RA JUGULAR DUAL-LUMEN CATHETER (PEDIATRIC), THE FOLLOWING COMPLICATIONS WERE REPORTED DURING ECMO: AIR IN CIRCUIT, CANNULA PROBLEMS, EMBOLI (CLOTS OR AIR), CIRCUIT CHANGE, THROMBOSIS/CLOTS IN CIRCUIT COMPONENT, CANNULATION SITE BLEEDING, AND POSITIVE CULTURE PRE- AND ON-EXTRACORPOREAL LIFE-SUPPORT (ECLS). NO DEATHS, ADDITIONAL ADVERSE PATIENT EFFECTS, OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571073 MC3 DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70413 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Required Intervention