BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MC3

    MDR report key: 21969150 · Received May 6, 2025

    Report

    Report Number
    3011468686-2025-00031
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    October 30, 2023
    Report Date
    May 6, 2025
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K180151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED TO MC3 FOR EVALUATION. THE FRACTURE IN THE CATHETER BODY NEAR THE MAXIMUM INSERTION MARK WAS CONFIRMED. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER AND OBSERVATIONS FROM THE INVESTIGATION CONCLUDE THAT THE FRACTURE WAS LIKELY CAUSED BY FATIGUE OVER THE 114 DAYS OF USE. NOTE: THIS EVENT WAS INITIALLY REPORTED BY MC3 INC. UNDER REPORT #3011468686-2023-00024. THIS REPORT IS BEING SUBMITTED TO CORRECT THE BELOW FIELDS: A2, A3, A4: PATIENT DETAILS ADDED. B1: REPORT TYPE UPDATED TO ADVERSE EVENT PRODUCT PROBLEM. B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT UPDATED. B5: UPDATED. D9: UPDATED. H1: TYPE OF REPORTABLE EVENT UPDATED TO SERIOUS INJURY. H3: UPDATED. H6: CODES UPDATED. 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

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 CRESCENT 28F CANNULA, IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE CANNULA WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN ON (B)(6) 2023. THE CANNULA WAS REPLACED AFTER CIRCUIT CHANGE; CANNULA UPSIZED TO 30. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULATION SITE WAS THE RIGHT IJ (INTERNAL JUGULAR). THE CANNULA WAS USED FOR 114 DAYS PRIOR TO FRACTURE. THE PATIENT WAS SITTING IN A CHAIR, MOVED BACK TO CSICU BED, THE PATIENT ACUTELY SLUMPED OVER AND AIR WAS NOTICED IN THE CIRCUIT, CODE CALLED AND NO SEDATION. THERE WERE NO CHEMICALS, CLEANING AGENTS APPLIED DIRECTLY TO CATHETER BODY. DRESSING CHANGE OCCURS AS NEEDED OR ONCE PER WEEK, IT IS PATIENT DEPENDENT AND WOUND CONDITION DEPENDENT. THE SURGEON WAS JUST OUTSIDE THE ROOM, AIR WAS NOTICED IN CIRCUIT, PATIENT CODED, THE SURGEON ADVISED BY PERFUSIONIST THAT THE CANNULA WAS THE ISSUE. AIR WAS PRESUMED TO BE USER ERROR WITH AIR INTRODUCTION TO CIRCUIT (SURGEON REQUESTED CIRCUIT CHANGE), SURGEON ADVISED AGAIN THAT THIS WAS A CANNULA ISSUE, CIRCUIT EXCHANGE COMPLETED, NOTICEABLE AIR IN CANNULA AFTER CIRCUIT CHANGE. THE CANNULA WAS EXCHANGED, AIR ISSUE RESOLVED PATIENT RESUSCITATED, SUBSEQUENT STROKE DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99341 MC3 DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70128 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| L