BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP+

    MDR report key: 25010154 · Received April 27, 2026

    Report

    Report Number
    2015691-2026-14744
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 27, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. BECAUSE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER IS NOT AVAILABLE. THE PRIMARY DEVICE IDENTIFIER (DI) NUMBER WAS NOT PROVIDED. 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. D2B. ADDITIONAL DEVICE PRODUCT CODE: DQO, DQE, KRA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE SWAN-GANZ VIP+ CATHETER HAD A LEAK ON THE CENTRAL VENOUS PRESSURE LINE AT THE PROXIMAL END, WHERE IT CONNECTS TO THE WHITE PART. PATIENT DRIPPED BLOOD AND CENTRAL VENOUS PRESSURE NUMBERS WERE NOT ACCURATE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47825 SWAN-GANZ VIP+ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 831F75

    Patients

    Seq Age Sex Outcome Treatment
    1