BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN

    MDR report key: 3843579 · Received June 2, 2014

    Report

    Report Number
    2015691-2014-01274
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE 111F7 CATHETERS WITH AN ATTACHED MONOJECT 3ML SYRINGE WITH 1.5 ML LIMITED VOLUME SYRINGE FOR EXAMINATION. THE REPORTED EVENT OF ¿THE BALLOON WOULD NOT DEFLATE" WAS NOT CONFIRMED. THE BALLOON INFLATED CLEAR AND CONCENTRIC FOR 5 MINUTES WITHOUT LEAKAGE. HOWEVER, THE BALLOON WAS FOUND TO HAVE RESIDUAL WATER INSIDE, CAUSING THE BALLOON TO DEFLATE SLOWLY. NOTE PER THE IFU THE BALLOON SHOULD BE INFLATED USING 1.5ML CO2. DEFLATION TIME WAS 5 SECONDS PRIOR TO VACUUMING LIQUID OUT FROM BALLOON. DEFLATION TIME THEN REDUCED TO 2 SECONDS AFTER VACUUMING LIQUID OUT FROM BALLOON WHICH WAS IN SPECIFICATION. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO OTHER VISUAL DAMAGE, CONTAMINATION, OR OTHER ABNORMALITIES FOUND ON THE CATHETER. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INFLATION TESTING, PRIOR TO USE, THE BALLOON WOULD NOT DEFLATE. IT WAS INDICATED THAT THE SYRINGE WAS REMOVED FROM THE GATE VALVE BY THE CLINICIAN WHEN TRYING TO DEFLATE THE BALLOON BUT THE BALLOON DID NOT DEFLATE. A 20CC SYRINGE WAS THEN USED TO OVER INFLATE THE BALLOON IN ORDER TO DEFLATE IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322019 SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO EDWARDS LIFESCIENCES PR 111F7 59691971

    Patients

    Seq Age Sex Outcome Treatment
    1