BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP+

    MDR report key: 24690978 · Received March 25, 2026

    Report

    Report Number
    2015691-2026-13517
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103151756
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: DQE, DQO, AND KRA. 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 THE BLUE LUMEN OF A SWAN GANZ CATHETER WAS COMPLETELY SEVERED IN HALF AFTER DEVELOPING A HOLE IN THE PROXIMAL PORT. A MIXTURE OF PATIENT BLOOD AND DEXTROSE 5% LEAKED FROM THE PORT. AN ARROW CORDIS 8.5FR WAS USED IN THE CASE. ONCE THE MALFUNCTION WAS NOTICED, THE SWAN GANZ WAS REMOVED FROM THE PATIENT. ISSUE OCCURRED 5 DAYS POST INSERTION. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747262 SWAN-GANZ VIP+ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 834F75 00690103151756

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown