BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN GANZ TRUE SIZE

    MDR report key: 21356399 · Received February 11, 2025

    Report

    Report Number
    2015691-2025-00931
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Report Date
    March 21, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQO
    UDI-DI
    00690103000245
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS REQUESTED TO BE RETURNED, BUT DID NOT ARRIVE FOR PRODUCT EVALUATION. THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE ISSUE. AS PART OF THE MANUFACTURING PROCESS 100 PERCENT OF THE BALLOONS GO THROUGH A BALLOON INSPECTION. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED WITH A MANUFACTURING OR DESIGN DEFECT. IT IS NOT KNOWN IF PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. 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 PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT YET ARRIVED. ONCE IT HAS ARRIVED AND THE PRODUCT EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL SUBMISSION WILL BE SENT. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. ADDITIONAL PRODUCT CODES, DYG, DQE, KRA.

    Description of Event or Problem · 0

    AS REPORTED, DURING SET UP, THERE WAS AN ISSUE WITH A SWAN GANZ CATHETER BALLOON. DURING TESTING OF THE BALLOON IT WOULD NOT PROPERLY INFLATE. IT WAS UNDERINFLATED AFTER TESTING AND THEN IT WOULD NOT DEFLATE. THERE WAS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708747 SWAN GANZ TRUE SIZE SWAN GANZ TRUE SIZE THERMODILUTION CATHETER DQO EDWARDS LIFESCIENCES 096F6 00690103000245

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown