BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24760543 · Received April 1, 2026

    Report

    Report Number
    2015691-2026-13779
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 1, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. 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, DURING USE, THE PROXIMAL INJECTION LUMEN OF A SWAN GANZ CATHETER HAD A CRACK THAT WAS DISTAL TO THE HUB. THE ISSUE OCCURED POST PROCEDURE. A LONG CLOT FORMED. AT THE TIME, THERE WAS BLOOD AROUND THE AREA SITE ON THE BLANKETS. SKIN CHECK WAS PERFORMED FROM HEAD TO TOE AND NO OTHER SOURCE OF BLEEDING WAS IDENTIFIED. CATHETER WAS REMOVED AND THE CORDIS WAS LEFT IN PLACE. PAC WAS PLACED ON (B)(6) 2026 AND REMOVED ON (B)(6) 2026. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817381 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75P 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown