BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE

    MDR report key: 21329054 · Received February 6, 2025

    Report

    Report Number
    2015691-2025-00839
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Report Date
    March 21, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQO
    UDI-DI
    00690103043273
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. WITHOUT 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. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH A BALLOON WINDING AND VISUAL INSPECTION PROCESS. AS A WARNING THE IFU STATES THAT BALLOON RUPTURE AND CATHETER SEPARATION AS A RESULT OF EXCESSIVE PULL FORCE APPLIED TO REMOVE ADHERENT MATERIAL ARE THE MOST FREQUENT CAUSES OF REPORTED FAILURES. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES. 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.

    Description of Event or Problem · 0

    AS REPORTED, DURING AN EMERGENCY THROMBECTOMY ON THE LEFT LOWER EXTREMITY THE PHYSICIAN REQUESTED A SIZE 2FR FOGARTY THROMBECTOMY CATHETER. THE SCRUB TECH TESTED THE CATHETER BALLOON WITH THE APPROPRIATE AMOUNT OF FLUID BEFORE HANDING TO THE SURGEON TO USE. IN THE PHYSICIAN'S ATTEMPT TO PERFORM THE THROMBECTOMY, AS THEY INFLATED THE BALLOON AND ATTEMPTED TO REMOVE IT FROM PATIENT'S EXTREMITY, THE BALLOON OF THE CATHETER DETACHED AND REMAINS STUCK INSIDE THE PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE HOWEVER NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DEVICE IS EXPECTED TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248338 SWAN-GANZ TRUE SIZE CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO EDWARDS LIFESCIENCES PR 120602F 65746748 00690103043273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown