BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24760621 · Received April 1, 2026

    Report

    Report Number
    2015691-2026-13782
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 23, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103218282
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, THE BLUE, PROXIMAL PORT OF A SWAN GANZ CATHETER WAS CRACKED AND LEAKING. THE ISSUE OCCURRED POST PROCEDURE. IT IS UNKNOWN WHAT LEAKED. LUMENS WERE FLUSHED, TUBING WAS CHANGED, AND CATHETER WAS REPOSITIONED. CATHETER WAS IN THE PATIENT FOR EITHER 3 DAYS TO 2 WEEKS. THERE WERE NO PATIENT INJURIES BUT A NEW INSERTION SITE WAS NEEDED FOR A NEW LINE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383337 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75P 66660610 00690103218282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown