BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO V

    MDR report key: 24849273 · Received April 11, 2026

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    Report

    Report Number
    2015691-2026-14089
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 20, 2026
    Report Date
    May 14, 2026
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. BECAUSE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER IS NOT AVAILABLE. THE PRIMARY DEVICE IDENTIFIER (DI) NUMBER WAS NOT PROVIDED. 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. D2B: ADDITIONAL DEVICE PRODUCT CODE: DQO, DXN, DQE, KRA, DQK, DRS, DSB, QAQ.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT EVALUATION AS AFFECTED UNIT WAS NOT RETURNED; THEREFORE, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED. COMPLAINTS INCIDENCE FOR BLOOD CLOTS WILL CONTINUE TO BE MONITORED, AND APPLICABLE ACTIONS WILL BE TAKEN AS REQUIRED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. WITHOUT RETURN OF THE DEVICE, A ROOT CAUSE COULD NOT BE DETERMINED. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH FLOW AND LEAK TEST INSPECTION. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST PROCEDURE THE SWAN-GANZ CCOMBO V HAD CLOTTING ISSUES. ON (B)(6), THE PATIENT HAD THE FIRST SWAN-GANZ, WHICH CLOTTED IMMEDIATELY UPON PATIENT RETURNING FROM THE CCL. THE SECOND SWAN-GANZ WAS PLACED ON THE SAME DAY (B)(6) AROUND 3PM. THIS CATHETER THEN CLOTTED LATER IN THE EVENING. THE PATIENT NEEDED MONITORING, DECISION WAS MADE TO INSTILL CATH FLO WHICH DID WORK BUT THEN CLOTTED ON (B)(6). SWAN-GANZ WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119315 SWAN-GANZ CCOMBO V CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 777F8

    Patients

    Seq Age Sex Outcome Treatment
    1