BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 25016987 · Received April 28, 2026

    Report

    Report Number
    2015691-2026-14756
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103146554
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: KRA, CATHETER, CONTINUOUS FLUSH. DQE, CATHETER, OXIMETER, FIBEROPTIC. DQO, CATHETER, INTRAVASCULAR, DIAGNOSTIC. THE DEVICE WILL NOT BE RETURNED. HOWEVER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION 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 OF THE SWAN GANZ CATHETER THE CVP PORT WHITE CAP BROKE OFF FROM BLUE TUBING. THERE WAS NO PATIENT INJURY. A SECOND PROCEDURE WAS PERFORMED TO HAVE A NEW CATHETER INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493954 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR SWAN GANZ UNKNOWN NI 00690103146554

    Patients

    Seq Age Sex Outcome Treatment
    1