BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 23686130 · Received December 1, 2025

    Report

    Report Number
    2015691-2025-09659
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Report Date
    January 6, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    UDI-DI
    00690103008753
    PMA / PMN Number
    K233983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BY THE HOSPITAL. WITHOUT THE 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. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED ASSOCIATED TO THE REPORTED MALFUNCTION. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT EVALUATION AS THE DEVICE WAS DISCARDED AND NOT RETURNED. WITHOUT ITS RETURN, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. AS PART OF THE MANUFACTURING PROCESS 100 PERCENT OF THE UNITS GO THROUGH A BALLOON INSPECTION PROCESS. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE IN PATIENT, THE RESISTANCE VALUE OF THIS SWAN-GANZ PACING CATHETER WAS CONTINUOUSLY HIGH, AND DID NOT SENSE OR PACE. THE CUSTOMER SUSPECTED THAT THE CATHETER HAD AN OPEN CONDITION. 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
    2265249 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR PE075F5 66022259 00690103008753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown