BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE

    MDR report key: 23830479 · Received December 17, 2025

    Report

    Report Number
    2015691-2025-10282
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 27, 2025
    Report Date
    February 27, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQO
    UDI-DI
    00690103177121
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES INCLUDE: DYG CATHETER, FLOW DIRECTED, DQE CATHETER, OXIMETER, FIBEROPTIC, KRA CATHETER, CONTINUOUS FLUSH. 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. THE DEVICE HISTORY RECORD REVIEW HAS NOT YET BEEN 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

    ONE SWAN GANZ CATHETER WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF BALLOON WAS FOUND RUPTURED AND MISSING WAS CONFIRMED. AS RECEIVED, BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA. THE RUPTURED EDGES DID NOT APPEAR MATCHING AT THE RUPTURE. THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO OTHER VISIBLE DAMAGE WAS FOUND FROM THE CATHETER BODY. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT ANY NONCONFORMANCES. AS PART OF THE CATHETER MANUFACTURING PROCESS, 100% OF THE MANUFACTURED UNITS GO THROUGH A BALLOON INFLATION AND VISUAL INSPECTION PROCESS. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESIGN DEFECT. THEREFORE A ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    AS REPORTED, WHEN REMOVING THE CATHETER ALONG WITH THE INTRODUCER AFTER RIGHT HEART CATHETERIZATION, THIS SWAN GANZ CATHETER WAS REMOVED WITHOUT DEFLATING THE BALLOON ALTHOUGH THE CUSTOMER THOUGHT THEY DEFLATED THE BALLOON. AFTER THE CATHETER REMOVAL, THE BALLOON WAS FOUND RUPTURED AND MISSING. THE CUSTOMER WAS UNABLE TO FIND THE BALLOON BY CHECKING THE INSIDE/OUTSIDE OF THE INTRODUCER AND AROUND THE BLOOD VESSEL AND USING ULTRASOUND. THIS INTRODUCER (MODEL NUMBER: CI70P35TSMK, BRAND: MEDIKIT, 7FR, 35CM, TYPE J) WAS USED FOR BIOPSY INITIALLY, AND THIS SWAN GANZ CATHETER WAS INSERTED THROUGH THIS INTRODUCER SUBSEQUENTLY. NO ADDITIONAL TREATMENT WAS REQUIRED DUE TO THIS EVENT. THE CUSTOMER CONSIDERED THAT THIS EVENT IS RELATED TO PROCEDURE ISSUE INSTEAD OF DEVICE MALFUNCTION. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335828 SWAN-GANZ TRUE SIZE CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO EDWARDS LIFESCIENCES PR 096F6J 66377569 00690103177121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown