BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO V

    MDR report key: 24835013 · Received April 9, 2026

    Report

    Report Number
    2015691-2026-14039
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 9, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103146554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: KRA, DQE, DQO. MEDWATCH (B)(4) WAS RECEIVED. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER INSERTION, UNKNOWN YELLOW FLUID WAS FOUND IN THE BALLOON OF A SWAN GANZ CATHETER. FLUID WAS SEEN IN THE BALLOON SYRINGE AND THEN IN THE BALLOON UPON REMOVAL OF THE CATHETER FROM THE PATIENT. ISSUE OCCURRED IN THE ICU. IT IS UNKNOWN IF THE PATIENT'S MEDICATION WAS THE SOURCE OF THE YELLOW FLUID. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890134 SWAN-GANZ CCOMBO V CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 777F8 00690103146554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male