BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 22857113 · Received August 20, 2025

    Report

    Report Number
    2015691-2025-06866
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    July 28, 2025
    Report Date
    September 26, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103218282
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES. THE PRODUCT WAS NOT RETURNED; HOWEVER, AN IMAGE EVALUATION WAS COMPLETED ON THE PROVIDED PHOTO AND VIDEO. THE REPORTED EVENT OF "LEAKAGE" WAS CONFIRMED. A STREAM OF COLORLESS LIQUID WAS OBSERVED LEAKING FROM THE JUNCTION OF THE PROXIMAL INJECTATE EXTENSION TUBE AND HUB. DURING THE EXECUTION OF THE ENGINEERING EVALUATION PROCESS, IT WAS IDENTIFIED THAT THE ASSEMBLY OF THE COMPONENTS WHERE THE LEAKAGE OCCURS IS NOT MANUFACTURED INTERNALLY IN THE MANUFACTURING PROCESS. CONSEQUENTLY, THIS IS A SUPPLIER RELATED CONDITION, AND THE CORRESPONDING SUPPLIER NOTIFICATION WAS SENT THROUGH MAIL BY THE QUALITY TEAM.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES: DQO, DQE, KRA, DQK, DRS, DSB, DXN, QAQ ADDITIONAL PREMARKET SUBMISSION: K231248. DEVICE IS NOT AVAILABLE FOR RETURN. 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. HOWEVER, AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE REPORTED LOT NUMBER. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING ONCE THE ENGINEERING EVALUATION IS COMPLETE. 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, DURING USE, A SWAN GANZ CATHETER HAD SALINE AND MEDICATION LEAK AT THE CVP PORT, WHERE THE WHITE FACTORY INSTALLED CAP JOINS THE BLUE TUBING. LEAKAGE OCCURRED 3 DAYS AFTER USE. CATHETER WAS REMOVED AS THE STAFF WAS UNABLE TO USE THE PORT. LOT NUMBER MAY BE 66225267 AS THIS WAS THE REMAINING LOT ON THE SHELF. THERE WERE NO PATIENT INJURIES, BUT PATIENT MAY HAVE HAD A NEW SWAN INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409969 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75P 66225267 00690103218282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown