BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 22801251 · Received August 13, 2025

    Report

    Report Number
    2015691-2025-06626
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 14, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODE: DQO, DQE, KRA, DQK, DRA, DSB, DXN, QAQ. ADDITIONAL PREMARKET SUBMISSION: K231248. 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 ON MEDWATCH MW5172405 THAT, DURING DEVICE PREP, THE SWAN GANZ CATHETER COULD NOT BE DEFLATED. CATHETER WAS REMOVED FROM THE STERILE FIELD AND A NEW CATHETER WAS OPENED TO RESOLVE THE ISSUE. NO ALLEGATION OF PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392959 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male