BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 22746640 · Received August 8, 2025

    Report

    Report Number
    2015691-2025-06437
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 8, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103150421
    PMA / PMN Number
    K233983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PREMARKET SUBMISSION NUMBER: K822723. DEVICE WAS DISCARDED BY THE HOSPITAL. 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. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, THE ELECTRODES OF A SWAN GANZ PACING CATHETER GOT STUCK IN A 3RD PARTY SHEATH. PATIENT WITH A RIGHT INTRAJUGULAR TEMPORARY WIRE IN PLACE CAME TO THE ELECTROPHYSIOLOGY LAB FOR A DEVICE PLACEMENT. AFTER THE PACEMAKER PROCEDURE WAS COMPLETED, TEMPORARY WIRE WAS PULLED UNDER FLUOROSCOPY. AFTER UNLOCKING THE VALVE OF THE SHEATH, THE WIRE WAS BEING PULLED WHILE LEAVING THE SHEATH IN PLACE. AS THE TEMPORARY WIRE WAS CLOSE TO EXITING THE SHEATH, RESISTANCE WAS FELT AND PROMPTED THE STAFF TO PULL SLIGHTLY HARDER. THIS CAUSED THE ELECTRODES TO BREAK OFF. TO PREVENT IT FROM MIGRATING INTO THE PATIENT'S CIRCULATORY SYSTEM, STAFF GRABBED A 10CC SYRINGE AND PULLED THE BLOOD BACK INTO THE SIDE PORT THEN IMMEDIATELY PULLED THE SHEATH TO REMOVE IT FROM THE PATIENT. WHILE PRESSURE WAS PLACED ON THE INTRAJUGULAR SITE, THE CIRCULATING NURSE BEGAN INSPECTING THE SHEATH. THE NURSE CUT THE SHEATH OPEN AND WAS ABLE TO FIND THE ELECTRODE PORTION OF THE WIRE ADHERED TO THE LOCKING PORTION OF THE SHEATH. HOWEVER, THE NURSE WAS NOT ABLE TO REMOVE IT AS IT WAS STUCK. THE PHYSICIAN ALSO VISUALLY INSPECTED IT AND CONFIRMED THAT NOTHING WAS LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233190 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR D97120F5 00690103150421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown