BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 24916251 · Received April 17, 2026

    Report

    Report Number
    2015691-2026-14467
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Report Date
    May 18, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    UDI-DI
    00690103008746
    PMA / PMN Number
    K233983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. 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

    AS REPORTED, DURING USE IN PATIENT FOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI), THIS SWAN-GANZ PACING CATHETER DID NOT PACE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER AND THE PROCEDURE CONTINUED. THERE IT WAS REPORTED THAT DURING USE IN PATIENT FOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI), THIS SWAN-GANZ PACING CATHETER DID NOT PACE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER AND THE PROCEDURE CONTINUED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254065 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR PE074F5 66285949 00690103008746

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown