BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2470207 · Received February 27, 2012

    Report

    Report Number
    2015691-2012-16982
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 1, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    KRB
    PMA / PMN Number
    K811411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RECEIVED WITH AN ATTACHED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE BALLOON DEFLATED WITHIN 2 SECONDS WITHOUT A SYRINGE ATTACHED, WHICH IS WITHIN THE ALLOWABLE SPECIFICATION. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO VISIBLE DAMAGE OBSERVED ON THE CATHETER BODY OR THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. THE REPORT OF DEFLATION DIFFICULTY WAS NOT CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. AS STATED IN THE PRODUCT IFU: "PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE". REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT DEVICE HANDLING (LEAVING THE SYRINGE ATTACHED WHILE DEFLATING) APPEARS TO HAVE CONTRIBUTED TO THIS REPORT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. IT WAS INDICATED THAT THE SYRINGE WAS ATTACHED TO DEFLATE AND THE SYRINGE SUPPLIED IN THE KIT WAS USED. A SECOND CATHETER WAS USED WITH NO OTHER ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD THERMODILUTION CATHETER KRB EDWARDS LIFESCIENCES, PR 131HF7 59153716

    Patients

    Seq Age Sex Outcome Treatment
    1