BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MC3

    MDR report key: 21968952 · Received May 6, 2025

    Report

    Report Number
    3011468686-2025-00029
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    May 9, 2022
    Report Date
    May 6, 2025
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    UDI-DI
    10854916006826
    PMA / PMN Number
    K180151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE CUSTOMER'S OBSERVATION OF A FRACTURE AT THE MAXIMUM INSERTION MARK WAS CONFIRMED DURING COMPLAINT DEVICE EVALUATION. THE CATHETER WAS KINKED AT THE BREACH SITE. A SUTURE WAS FOUND ON THE DEVICE, TIED DIRECTLY TO THE CATHETER BODY IN THE WIRE REINFORCEMENT SECTION. LONGITUDINAL CUT MARKS WERE ALSO FOUND ON THE CATHETER. THE INK FOR LABELING THE FRENCH SIZE AND CLAMPABLE SECTION OF THE CATHETER WAS FADED. NOTE: THIS EVENT WAS INITIALLY REPORTED BY MC3 INC. UNDER REPORT #3011468686-2022-00009. THIS REPORT IS BEING SUBMITTED TO CORRECT THE BELOW FIELDS: B1: REPORT TYPE UPDATED TO ADVERSE EVENT PRODUCT PROBLEM. B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT UPDATED. B5: UPDATED. H1: TYPE OF REPORTABLE EVENT UPDATED TO SERIOUS INJURY. 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 A MC3 CRESCENT JUGULAR CATHETER, THE CUSTOMER REPORTED THAT WHILE PREPARING TO DECANNULATE THE CRESCENT CATHETER FROM THE PATIENT, CUSTOMER NOTICED THE CATHETER HAD A GURGLING SOUND. UPON VISUAL EXAMINATION THEY OBSERVED THE CRESCENT CATHETER WAS FRACTURED, THUS NECESSITATING IMMEDIATE CESSATION OF EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) FLOW. THE DEVICE HAD BEEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER DECANNULATION OF THE CRESCENT CATHETER, THE SURGEON PERFORMED AN EMERGENT INSERTION OF CVC WITH SWAN-GANZ CATHETER ASSISTED AIR EMBOLISM EXTRACTION DUE TO ACUTE AIR EMBOLISM SECONDARY TO CRESCENT CATHETER FRACTURE. THE PATIENT ANATOMY DID NOT CONTRIBUTE TO THE ISSUE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT THE DEVICE WAS USED FOR 30 PLUS DAYS AND THE STANDARD INSERTION TECHNIQUE WAS PERCUTANEOUS IN THE RIGHT INTERNAL JUGULAR WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832728 MC3 DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70132 2201214 10854916006826

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention