BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 22929357 · Received August 29, 2025

    Report

    Report Number
    2015691-2025-07162
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 29, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103150438
    PMA / PMN Number
    K233983
    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 PREMARKET SUBMISSION: K822723. MEDWATCH MW5173232 WAS RECEIVED. IT WAS REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN. WITHOUT 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. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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 THE TIP OF A SWAN GANZ PACING CATHETER WAS MISSING AFTER IT WAS PULLED OUT OF THE RIGHT FEMORAL VEIN. THERE WAS NO PATIENT INJURY. CONTACT INFORMATION WAS NOT PROVIDED SO FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212631 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR D97130F5 00690103150438

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown