BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24217948 · Received January 29, 2026

    Report

    Report Number
    2015691-2026-10656
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Report Date
    January 29, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES INCLUDE DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQE CATHETER, OXIMETER, FIBEROPTIC KRA CATHETER, CONTINUOUS FLUSH DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE DRS TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DSB PLETHYSMOGRAPH, IMPEDANCE DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE QAQ ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR THE DEVICE WILL NOT BE RETURNED FOR PRODUCT EVALUATION. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT OR IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS A LOT 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.

    Description of Event or Problem · 0

    AS REPORTED DURING USE THE SWAN GANZ CATHETER WAS CLOTTING OFF. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271741 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown