BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 24915833 · Received April 17, 2026

    Report

    Report Number
    2015691-2026-14464
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 17, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K233983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. G4. ADDITIONAL PMA/510K: K822723.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE IN PATIENT, THIS SWAN-GANZ PACING CATHETER DID NOT PACE FROM THE BEGINNING OF PROCEDURE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970767 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR PE074F5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown