BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTROLCATH TRUE SIZE

    MDR report key: 21865822 · Received April 18, 2025

    Report

    Report Number
    2015691-2025-03017
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 27, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQO
    UDI-DI
    00690103005134
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE COMPLAINT AFFECTED PRODUCT WAS NOT RETURNED FOR EVALUATION; 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. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE BEING EVALUATED TO BE ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE MANUFACTURED UNITS GO THROUGH A BALLOON INFLATION PROCESS INSPECTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES ARE: DYG, DQE, KRA. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION AND TO SECURE THE RETURN OF THE DEVICE. HOWEVER, THE CUSTOMER HAS NOT RESPONDED NOR SENT THE DEVICE BACK 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. HOWEVER, AN INVESTIGATION WILL BE INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE LOT NUMBER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING DEVICE PREP, THE BALLOON OF A SWAN GANZ CATHETER COULD NOT DEFLATE. THERE WERE NO PATIENT INJURIES REPORTED. FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680881 SWAN-GANZ CONTROLCATH TRUE SIZE CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO EDWARDS LIFESCIENCES PR C144F7 65691678 00690103005134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown