BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO V

    MDR report key: 24885255 · Received April 15, 2026

    Report

    Report Number
    2015691-2026-14366
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Report Date
    May 6, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. WITHOUT 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. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. BECAUSE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER IS NOT AVAILABLE. THE PRIMARY DEVICE IDENTIFIER (DI) NUMBER WAS NOT PROVIDED. 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. D2B. ADDITIONAL DEVICE PRODUCT CODE: DQO,DQE, KRA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE SWAN-GANZ CCOMBO V HAD CLOTTING ISSUES. THE SWAN-GANZ IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555160 SWAN-GANZ CCOMBO V CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 777F8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown