BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ HI-SHORE TRUE SIZE

    MDR report key: 24482189 · Received March 2, 2026

    Report

    Report Number
    2015691-2026-11649
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    December 18, 2025
    Report Date
    May 13, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQO
    UDI-DI
    00690103000504
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DYG- CATHETER, FLOW DIRECTED KRA- CATHETER, CONTINUOUS FLUSH DQE- CATHETER, OXIMETER, FIBEROPTIC. 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 BEFORE USE OF THE SWAN-GANZ CATHETER IT WOULD NOT TRANSDUCE AN ACCURATE PRESSURE. SHOWED RV OVER PA PRESSURE. THE USER TRIED MULTIPLE TRANSDUCERS WITHOUT SUCCESS. A NEW SWAN-GANZ CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389379 SWAN-GANZ HI-SHORE TRUE SIZE CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO EDWARDS LIFESCIENCES PR 141F7 NI 00690103000504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown