BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 25204273 · Received May 18, 2026

    Report

    Report Number
    2015691-2026-15291
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 18, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    UDI-DI
    00690103008753
    PMA / PMN Number
    K233983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL 510K CODE: K822723.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CATHETER INSERTION DURING USE IN PATIENT, THIS SWAN-GANZ PACING CATHETER DID NOT PACE FROM THE BEGINNING OF PROCEDURE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240450 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR PE075F5 66260934 00690103008753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown