BEUDAMED
    FDA Adverse Event Death Summary report: N

    MC3

    MDR report key: 25253169 · Received May 22, 2026

    Report

    Report Number
    3011468686-2026-00038
    Event Type
    Death
    Date Received
    May 22, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K203409
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    B.5.MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE DID NOT MALFUNCTION, IT APPEARED AS THOUGH WHEN IT WAS PLACED, THE CANNULA PERFORATED THE RIGHT ATRIUM AND CAUSED FATAL BLEEDING.THE BLOOD LOSS WAS RELATED TO THE USE OF THE DEVICE.A HOLE IN ATRIUM LED TO TAMPONADE. CHEST WAS OPEN AND CPR WAS PERFORMED BUT NOT ABLE TO REVIVE BABY. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PROCEDURE BEING CARRIED OUT WAS THE PLACEMENT OF A CRESCENT RA IN THE RIGHT JUGULAR. 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

    IT WAS REPORTED THAT DURING INSERTION OF THE MC3 CRESCENT RA JUGULAR DUAL-LUMEN CATHETER, THE RIGHT ATRIUM WAS PERFORATED DESPITE USE OF A NORMAL PLACEMENT PROTOCOL WITH FLUOROSCOPY. BLOOD LOSS WAS REPORTED. SHORTLY AFTER INSERTION, THE BABY DECOMPENSATED AND CARDIAC TAMPONADE WAS DETERMINED TO BE THE CAUSE OF THE DECOMPENSATION. THE CHEST WAS OPENED AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED AS TREATMENT EFFORTS. THE BABY DIED, AND THE PHYSICIAN INDICATED THE PROCEDURE CAUSED OR CONTRIBUTED TO THE DEATH; IT WAS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509724 MC3 DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70413 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1