BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 22857256 · Received August 20, 2025

    Report

    Report Number
    2015691-2025-06870
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 5, 2025
    Report Date
    October 31, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES: DQO, DQE, KRA, DQK, DRS, DSB, DXN, QAQ. ADDITIONAL PREMARKET SUBMISSION: K231248. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    A PRODUCT INVESTIGATION WAS COMPLETED ON THE RETURNED CATHETER. THE REPORTED EVENT OF "LEAKAGE WHERE THE WHITE PROXIMAL INJECTATE AND BLUE TUBING CONNECT" WAS CONFIRMED. VISUAL EXAMINATION FOUND THAT PROXIMAL INJECTATE EXTENSION TUBE WAS PARTIALLY BROKEN AT THE LUMEN HUB. CROSS SURFACE OF THE BROKEN EXTENSION TUBE APPEARED TO BE UNEVEN AND ROUGH. ALL OTHER THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR MORE THAN 5 MINUTES WITHOUT LEAKAGE. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. A SUPPLIER NOTIFICATION WAS SENT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, A SWAN GANZ CATHETER HAD MEDICATION LEAKAGE WHERE THE WHITE "PROXIMAL INJECTATE" AND BLUE TUBING CONNECT. LEAKAGE OCCURRED 6 DAYS AFTER INSERTION. NO ALLEGATION OF PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372464 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75P 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown