BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO V

    MDR report key: 24719719 · Received March 30, 2026

    Report

    Report Number
    2015691-2026-13609
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Report Date
    March 27, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103146554
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: KRA, CATHETER, CONTINUOUS FLUSH. DQE, CATHETER, OXIMETER, FIBEROPTIC. DQO, CATHETER, INTRAVASCULAR, DIAGNOSTIC. 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 USE OF THE SWAN-GANZ CATHETER, WHEN DRAWING BLOOD FROM THE PA DISTAL LUMEN, THE CATHETER ASPIRATED AIR. THE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT REPLACEMENT AS BLOOD SAMPLING WAS PERFORMED BEFORE THE CATHETER REMOVAL. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774706 SWAN-GANZ CCOMBO V CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 777F8 NI 00690103146554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown