BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN GANZ CATHETER

    MDR report key: 21995312 · Received May 9, 2025

    Report

    Report Number
    2015691-2025-03698
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    March 1, 2025
    Report Date
    May 9, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    UDI-DI
    00690103198430
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED SO THERE WILL BE NO PRODUCT RETURN AND A PRODUCT EVALUATION IS UNABLE TO BE COMPLETED. THE MODEL AND LOT NUMBER OF THE DEVICE ARE UNKNOWN SO THE DEVICE HISTORY RECORD REVIEW IS UNABLE TO BE COMPLETED. ADDITIONAL PRODUCT CODES, DQE, DQO. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE PATIENT USE WITH A PULMONARY ARTERY CATHETER, THE INTRODUCER CATHETER TIP CRACKED AND ALL THE CONTINUOUSLY INFUSING MEDICATIONS LEAKED OUT. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. THE INFORMATION WAS PROVIDED THROUGH A VOLUNTARY MEDWATCH. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020949 SWAN GANZ CATHETER CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES 00690103198430

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown