BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 24948896 · Received April 22, 2026

    Report

    Report Number
    2015691-2026-14580
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 22, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    UDI-DI
    00690103008746
    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. G4. ADDITIONAL PMA/510K: 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. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER WITH THE SAME LOT NUMBER. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272624 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR PE074F5 66524855 00690103008746

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown