BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE

    MDR report key: 20291947 · Received September 24, 2024

    Report

    Report Number
    2015691-2024-07327
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 28, 2024
    Report Date
    November 26, 2024
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQO
    UDI-DI
    00690103000245
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA 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 RESULTS BECOME AVAILABLE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    ONE MODEL 096F6 CATHETER WITH A 1 ML SYRINGE WAS RETURNED FOR EVALUATION. THE REPORTED ISSUE OF BALLOON WOULD NOT DEFLATE WAS UNABLE TO BE CONFIRMED. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE BALLOON DEFLATED WITHIN 1 SECOND WITHOUT THE SYRINGE ATTACHED. MAXIMUM DEFLATION TIME FOR FULL CAPACITY IS 4 SECONDS. AS STATED IN THE IFU, PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE AND OPENING THE GATE VALVE. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED ON THE CATHETER. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE ISSUE OF BALLOON NOT ABLE TO DEFLATE WAS UNABLE TO BE CONFIRMED THROUGH PRODUCT EVALUATION SINCE THE AFFECTED UNIT WAS RETURNED FOR EVALUATION AND NO DEFECT WAS FOUND. THEREFORE, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE IFU ALSO CONTAINS THE FOLLOWING PRECAUTIONS: IT IS RECOMMENDED THAT THE PROVIDED SYRINGE BE RE-ATTACHED TO THE GATE VALVE AFTER BALLOON DEFLATION TO PREVENT INADVERTENT INJECTION OF LIQUIDS INTO THE BALLOON LUMEN; IF A RIGHT VENTRICULAR PRESSURE TRACING IS STILL OBSERVED AFTER ADVANCING THE CATHETER SEVERAL CENTIMETERS BEYOND THE POINT WHERE THE INITIAL RIGHT VENTRICULAR PRESSURE TRACING WAS OBSERVED, THE CATHETER MAY BE LOOPING IN THE RIGHT VENTRICLE WHICH CAN RESULT IN KINKING OR KNOTTING OF THE CATHETER. DEFLATE THE BALLOON AND WITHDRAW THE CATHETER INTO THE RIGHT ATRIUM. RE-INFLATE THE BALLOON AND RE-ADVANCE THE CATHETER TO A PULMONARY ARTERY WEDGE POSITION, THEN DEFLATE THE BALLOON. 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 THIS MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN TESTING A SWAN BEFORE INSERTING INTO THE PATIENT THE BALLOON WOULD NOT DEFLATE. THE DOCTOR AND REP BOTH ATTACHED/REATTACHED THE SYRINGE TO THE BALLOON, TRIED TO DEFLATE IT, BUT IT STAYED INFLATED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016007 SWAN-GANZ TRUE SIZE CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO EDWARDS LIFESCIENCES PR 096F6P 65612307 00690103000245

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown