BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 23262384 · Received October 9, 2025

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    Report

    Report Number
    2015691-2025-08232
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 11, 2025
    Report Date
    December 18, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DYG
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SWAN GANZ CATHETER WAS RETURNED FOR EVALUATION. REPORT OF BROKEN CATHETER ISSUE WAS CONFIRMED. CATHETER BODY APPEARED STRETCHED AND WAS BROKEN INTO HALVES AT APPROXIMATELY 15 CM FROM CATHETER TIP. CROSS SURFACE OF BROKEN SECTION APPEARED UNEVEN AND ROUGH. EDGES OF THE BROKEN CATHETER BODY APPEARED TO MATCH. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED ASSOCIATED TO THE REPORTED MALFUNCTION. THERE ARE MANUFACTURING CONTROLS TO AVOID POTENTIAL CAUSES RELATED TO THE CATHETER BODY BROKEN MALFUNCTION THAT INCLUDE 100% VISUAL INSPECTION AND 100% LEAK TEST. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES INCLUDE: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC. DQE CATHETER, OXIMETER, FIBEROPTIC. KRA CATHETER, CONTINUOUS FLUSH. DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE. DRS TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR. DSB PLETHYSMOGRAPH, IMPEDANCE. DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. QAQ ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 0

    AS REPORTED DURING BEDSIDE REMOVAL OF THE SWAN GANZ CATHETER THE LAST PART OF THE CATHETER WAS MISSING. THE INTRODUCER WAS REMOVED AND IT WAS NOTED TO HAVE AN ESTIMATED 6 INCHES OF THE SWAN GANZ CATHETER STILL ATTACHED TO THE INTRODUCER. THE INTRODUCER USED WAS AN INTRODUCER KIT HEMOSTASIS VALVE SIDEPORT WITH GUIDEWIRE 0.035 IN 8.5 FR, 10 CM. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703326 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES DR 831F75P 66301299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown