BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24760642 · Received April 1, 2026

    Report

    Report Number
    2015691-2026-13784
    Event Type
    Malfunction
    Date Received
    April 1, 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 POST PROCEDURE, THE BLUE, PROXIMAL PORT OF A SWAN GANZ CATHETER WAS CRACKED AND LEAKING. 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
    625475 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75P 66826032 00690103218282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown