BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24546861 · Received March 9, 2026

    Report

    Report Number
    2015691-2026-12659
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    January 23, 2026
    Report Date
    May 19, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K160084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 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, DQK, DRS, DSB, DXN, QAQ. G4. ADDITIONAL 510K: K231248.

    Description of Event or Problem · 0

    DURING USE, IT WAS REPORTED THAT THE SWAN GANZ VIP TD CATHETER HAD A FRACTURE OF THE PROXIMAL INJECTATE LUMEN WHERE THE WHITE CONNECTOR ENTERS THE BLUE TRANSPARENT TUBING. PRESSURE TUBING AND THE CO-SET WERE ATTACHED TO THE AFFECTED LUMEN. THE CATHETER AND TUBING WERE SECURED WITH A PULMONARY ARTERY CATHETER SECUREMENT DEVICE. IT WAS UNDETERMINED WHAT WAS INFUSING THROUGH THE PROXIMAL INJECTATE LUMEN AT THE TIME OF THE LEAKAGE. ON (B)(6) 2026, THE PATIENT'S BLOOD CULTURE WAS POSITIVE FOR ENTEROCOCCUS FAECALIS. NO OTHER PATIENT HARM WAS NOTED. THE CLINICAL RATIONALE FOR LONG-TERM MONITORING WITH THE CATHETER PLACED ON (B)(6) 2026, WAS MITRAL VALVE REPLACEMENT, TRICUSPID VALVE REPLACEMENT AND USE OF IMPELLA HEART PUMP. MVR, TVR, AND IMPELLA PLACEMENT.

    Description of Event or Problem · 0

    SUBMITTING CORRECTION: B1, B2. SUBMITTING CORRECTION: H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301978 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 831F75

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other