BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN

    MDR report key: 1905201 · Received November 22, 2010

    Report

    Report Number
    2015691-2010-14417
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF "BALLOON WAS INFLATING BUT NOT DEFLATING" WAS NOT CONFIRMED. THE BALLOON INFLATED CLEARLY, AND CONCENTRICALLY, AND REMAINED INFLATED WITHIN SPECIFICATION AND WITHOUT LEAKAGE OBSERVED. THE BALLOON DEFLATED WITHIN 2 SECONDS WITHOUT A SYRINGE ATTACHED, WHICH IS WITHIN THE SPECIFICATION OF 4 SECONDS. ALL THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE. THERE WAS NO VISIBLE DAMAGE OBSERVED TO CATHETER BODY OR TO THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. INTRODUCER AND CONTAMINATION SHIELD WERE NOT RETURNED. THE DIRECTIONS FOR USE INSTRUCT THE OPERATOR TO "ADVANCE THE CATHETER UNTIL PULMONARY CAPILLARY WEDGE PRESSURE (PAWP) IS OBTAINED, THEN PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE. DO NOT FORCEFULLY ASPIRATE AS THIS MAY DAMAGE THE BALLOON. AFTER DEFLATION, RE-ATTACH THE SYRINGE". IT IS UNKNOWN IN THIS CASE IF THE CUSTOMER REMOVED THE SYRINGE DURING DEFLATION; HOWEVER, IF THE SYRINGE WAS USED, THIS MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY IN DEFLATING THE BALLOON." A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE MET SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER HAD A FAULTY BALLOON, THE BALLOON WAS INFLATING, BUT NOT DEFLATING. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN MONITORING CATHETER DQO EDWARDS LIFESCIENCES, PR 111F7 58896823

    Patients

    Seq Age Sex Outcome Treatment
    1