BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24471064 · Received February 27, 2026

    Report

    Report Number
    2015691-2026-11605
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 3, 2026
    Report Date
    April 10, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103218282
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE TO SECURE THE RETURN OF THE PRODUCT BUT PRODUCT WAS NOT RETURNED. 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. WITH THE PROVIDED LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES. IF THE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: DQO, DQE, KRA, DQK, DRS, DSB, DXN, QAQ. ADDITIONAL PREMARKET SUBMISSION: K231248. 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, WHILE TRYING TO FLOAT A SWAN GANZ CATHETER, THE BALLOON WAS NOT SYMMETRICAL AND HAD INACCURATE PULMONARY ARTERY READINGS. NO ALLEGATIONS OF PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51028 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75P 66964714 00690103218282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown