BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24849282 · Received April 11, 2026

    Report

    Report Number
    2015691-2026-14091
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Report Date
    May 13, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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, DXN, DQE, KRA, DQK, DRS, DSB, QAQ G4. ADDITIONAL PMA/510K: K231248.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ VIP CATHETER WHILE BEING PLACED, IT IMMEDIATELY STARTED CLOTTING. CLOTTING HAS BEEN EXPERIENCED WITH SWANS WITHIN 24 HOURS OF PLACEMENT. ON (B)(6) 2026, PATIENT HAD A SWAN PLACED AND A FEW HOURS LATER CLINICIANS WERE UNABLE TO OBTAIN A WAVEFORM OR FLUSH THE PULMONARY ARTERY CATHETER (PA) PORT IN THE ICU. A NEW SWAN WAS PLACED IN THE CATH LAB, HOWEVER UPON ARRIVAL BACK IN THE ICU, THE NEW CATHETER COULD NOT BE FLUSHED, AND A WAVEFORM READING COULD NOT BE OBTAINED. NO ALLEGATION OF PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119490 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR SWAN GANZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown