BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP+

    MDR report key: 24583478 · Received March 12, 2026

    Report

    Report Number
    2015691-2026-13157
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 24, 2026
    Report Date
    May 26, 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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DQE- CATHETER, OXIMETER, FIBEROPTIC. DQO- CATHETER, INTRAVASCULAR, DIAGNOSTIC. KRA- CATHETER, CONTINUOUS FLUSH. 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 OF THE SWAN GANZ CATHETER THE PORT OF THE PA CATHETER WAS FOUND TO HAVE SPONTANEOUSLY SEVERED AT THE POINT WHERE THE BLUE PORT CONNECTS TO THE WHITE HUB. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595501 SWAN-GANZ VIP+ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 834F75 NI 00690103151756

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown