BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 22290191 · Received June 19, 2025

    Report

    Report Number
    2015691-2025-04989
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 7, 2025
    Report Date
    August 1, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103150421
    PMA / PMN Number
    K233983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE TO SECURE RETURN OF THE DEVICE HOWEVER THE CUSTOMER HAS NOT RESPONDED NOR SENT THE DEVICE BACK FOR EVALUATION. WITHOUT THE RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. SINCE THE COMPLAINT AFFECTED UNIT WAS NOT RETURNED FOR EVALUATION A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE ASSOCIATED TO MANUFACTURING OR DESIGN COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE INSTRUCTIONS FOR USE STATES PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: THIS CATHETER REQUIRES SPECIAL TECHNIQUES FOR INSERTION AND REMOVAL. ELECTRODE DISLODGEMENT MAY RESULT FROM PULLING THE CATHETER OUT THROUGH THE PERCUTANEOUS SHEATH. AVOID FORCEFUL WIPING OR STRETCHING OF THE CATHETER DURING TESTING AND CLEANING AS NOT TO BREAK THE ELECTRODE WIRE CIRCUITRY. SINCE PROPER FUNCTIONING OF THE PACING CATHETER DEPENDS ON THE ELECTRICAL CONTINUITY OF ITS ELECTRODES AND INTERNAL WIRES, CARE SHOULD BE EXERCISED WHEN HANDLING THE CATHETER.

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PREMARKET SUBMISSION: K822723. IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED. WITHOUT THE RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AN INVESTIGATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE LOT NUMBER. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, A SWAN GANZ CATHETER DID NOT CAPTURE APPROPRIATELY. ISSUE OCCURRED IN THE CATH LAB. THERE WAS NO PATIENT HARM AND ISSUE DID NOT CAUSE A DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640136 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR D97120F5 65982691 00690103150421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown