BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE

    MDR report key: 23538486 · Received November 12, 2025

    Report

    Report Number
    2015691-2025-09225
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 17, 2025
    Report Date
    January 21, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQO
    UDI-DI
    00690103177121
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES: DYG, DQE, KRA. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS NO LOT NUMBER WAS 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.

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED CATHETER. THE REPORTED EVENT OF ASPIRATION ISSUE WAS CONFIRMED. WHEN AIR WAS INJECTED INTO PA DISTAL LUMEN, LEAKAGE WAS OBSERVED FROM THERMISTOR CONNECTOR. AN INTERLUMEN LEAKAGE WAS OBSERVED BETWEEN THE PA DISTAL AND THERMISTOR LUMENS AT THE BACKFORM. OTHER THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY AND RETURNED SYRINGE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES. BASED ON THE AVAILABLE INFORMATION, A MANUFACTURING DEFECT CANNOT BE CONFIRMED. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH A BALLOON INFLATION INSPECTION AND LEAK TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, BEFORE USE IN PATIENT, A SWAN-GANZ CATHETER HAD AIR ASPIRATION. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE DETAILS REGARDING DEFECTIVE LUMEN IS UNCLEAR. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511827 SWAN-GANZ TRUE SIZE CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO EDWARDS LIFESCIENCES PR 096F6J 66373966 00690103177121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown