BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 23659221 · Received November 26, 2025

    Report

    Report Number
    2015691-2025-09604
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 22, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES: DQO, DQE, KRA, DQK, DRS, DSB, DXN, QAQ. ADDITIONAL PREMARKET SUBMISSION: K231248. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS 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.

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION AND TO SECURE THE RETURN OF THE DEVICE. HOWEVER THE CUSTOMER HAS NOT RESPONDED NOR SENT THE DEVICE BACK 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. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH A BALLOON INFLATION, VISUAL INSPECTION, AND INSPECTED FOR LEAK AND FLOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, THE CENTRAL VENOUS PRESSURE PORT OF A SWAN GANZ CATHETER LEAKED. CATHETER WAS PLACED ON (B)(6) 2025. IT IS UNKNOWN WHAT LEAKED FROM THE CATHETER. FURTHER INFORMATION IS NOT AVAILABLE. NO ALLEGATION OF PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812271 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown