BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 23032362 · Received September 11, 2025

    Report

    Report Number
    2015691-2025-07506
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 19, 2025
    Report Date
    November 21, 2025
    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 EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW HAS NOT YET BEEN 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.

    Additional Manufacturer Narrative · 0

    ONE SWAN-GANZ BIPOLAR PACING CATHETER WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF UNABLE TO PACE WAS CONFIRMED. CONTINUITY TESTING CONFIRMED THE FULL OPEN CONDITION OF THE DISTAL CIRCUIT. CUT DOWN OF THE CATHETER BODY WAS PERFORMED TO EXPOSE THE PACING LEAD WIRES. DISTAL LEAD WIRE WAS FOUND TO BE BROKEN UNDER THE BALLOON. PROXIMAL CIRCUIT WAS CONTINUOUS. NO VISIBLE DAMAGE OR ABNORMALITY WAS OBSERVED FROM CATHETER BODY OR BALLOON. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3 CC AIR AND REMAINED INFLATED FOR 5 MIN WITHOUT LEAKAGE. ENGINEERING TASK ASSIGNED FOR FURTHER INVESTIGATION. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION THE FAILURE PACING CATHETER BROKEN LEADWIRE DISTAL CANNOT BE ASSOCIATED TO A MANUFACTURING DEFECT, AS CUSTOMER REPORTED IT WAS DURING PROCEDURE. THEREFORE, A ROOT CAUSE COULD NOT BE IDENTIFIED AT THIS TIME. AS PER MANUFACTURING PROCESS, A VERIFICATION OF THE NICKEL MAGNET BIFILAR FOR DELAMINATION AND THE INSERTION OF THE WIRE INTO THE CATHETER TUBE AS PER THE PROCEDURE. A FINAL CONTINUITY TEST IS PERFORMED TO THE ELECTRODES AS PER THE PROCEDURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RIGHT AFTER INSERTION IN PATIENT, THIS SWAN-GANZ PACING CATHETER DID NOT PACE. THIS CATHETER WAS TO BE USED FOR TAVI. WHEN THIS CATHETER WAS REPLACED, THE PROBLEM WAS SOLVED. THE SIZE OF THE SHEATH INTRODUCER USED WITH THIS CATHETER IS UNKNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2706657 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR PE075F5 65982693 00690103008753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown