BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 25249763 · Received May 21, 2026

    Report

    Report Number
    2015691-2026-15434
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 21, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    UDI-DI
    00690103150438
    PMA / PMN Number
    K233983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. 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: K822723.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THIS SWAN GANZ PACING CATHETER WAS UNABLE TO PACE. THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527247 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES D97130F5 66548416 00690103150438

    Patients

    Seq Age Sex Outcome Treatment
    1