BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRESCENT RA DUAL LUMEN CATHETER 13FR

    MDR report key: 20616529 · Received November 6, 2024

    Report

    Report Number
    3011468686-2024-00034
    Event Type
    Death
    Date Received
    November 6, 2024
    Report Date
    November 5, 2024
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K203409
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT EXPLAINS THAT THERE IS NO SUSPICION OF MANUFACTURING DEFECT PRESENT AND THAT THE LENGTH OF USE AND DEVICE POSITION MAY CONTRIBUTE TO THE DEVICE FAILURE. THE MITIGATION STRATEGIES AND POTENTIAL EARLY WARNING SIGNS OUTLINED IN THE REPORT SHOULD BE CONSIDERED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION INFORMATION VIA LITERATURE REGARDING THE USE OF A CRESCENT CATHETER. IT WAS REPORTED THAT THE CATHETER HAD A FRACTURE, CRACK, OR BREAK, AND THE PATIENT SUFFERED MASSIVE AIR ENTRAINMENT INTO THE EXTRACORPOREAL CIRCUIT, RESULTING IN PATIENT HARM AND/OR DEATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED. ONE OF THE CASES IDENTIFIED IN THE LITERATURE WAS PREVIOUSLY REPORTED TO MEDTRONIC, 3011468686-2024-00014. THE 2ND CASE IDENTIFIED IN THE LITERATURE WAS NOT FOUND TO HAVE BEEN REPORTED TO MEDTRONIC PREVIOUSLY. THIS REPORT IS FOR THE 2ND CASE. ADDITIONAL INFORMATION COULD NOT BE OBTAINED FROM THE HOSPITAL AND THE DETAILS OF THE 2ND CASE ARE UNCONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132889 CRESCENT RA DUAL LUMEN CATHETER 13FR DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70413

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| O| D