BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 24947903 · Received April 21, 2026

    Report

    Report Number
    2015691-2026-14576
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Report Date
    April 21, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    KRA
    PMA / PMN Number
    K160084
    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: DQE- CATHETER, OXIMETER, FIBEROPTIC, DQO- CATHETER, INTRAVASCULAR, DIAGNOSTIC, DYG- CATHETER, FLOW DIRECTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE 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. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS UNDERGO AN EXTENSION PULL TEST AND LEAK INSPECTION. 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
    483672 SWAN-GANZ CATHETER, CONTINUOUS FLUSH KRA EDWARDS LIFESCIENCES PR SWAN GANZ UNKNOWN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown