BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 24691245 · Received March 25, 2026

    Report

    Report Number
    2015691-2026-13519
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 25, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQO
    UDI-DI
    00690103000405
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES: KRA, DYG, DQE. 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 A NURSE FOUND BLOOD BACKING UP THROUGH THE BLUE PORT OF A SWAN GANZ CATHETER AND "THE END PIECE HAD FALLEN OFF". ISSUE OCCURRED POST PROCEDURE WHILE IN THE CRITICAL CARE UNIT AND WAS RESOLVED BY REMOVING THE LINE. CATHETER WAS INSIDE THE PATIENT FOR 8 DAYS. THERE WAS MINIMAL BLOOD LOSS BUT OVERALL, THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463406 SWAN-GANZ CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO EDWARDS LIFESCIENCES PR 131F7 00690103000405

    Patients

    Seq Age Sex Outcome Treatment
    1