BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 3173630 · Received June 17, 2013

    Report

    Report Number
    2015691-2013-20368
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K924452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER THAT WAS RETURNED FOR EVALUATION DID NOT INFLATE DUE TO LEAKAGE AND WITH LATEX MATERIAL MISSING. EXAMINATION REVEALED THAT THE BALLOON FAILED TO INFLATE DUE TO LEAKAGE OBSERVED THROUGH A TEAR, APPROXIMATELY 0.040" IN LENGTH NEAR THE DISTAL BOND. THE EDGES OF THE LATEX DO NOT APPEAR TO MATCH UP AT THE AREA OF THE TEAR. THE BALLOON WAS IMMERSED IN WATER AND PRESSURIZED WITH AIR TO VISUALLY DETERMINE SOURCE OF LEAKAGE. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO VISIBLE DAMAGE OBSERVED FROM THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. UPON REMOVAL OF THE CONTAMINATION SHIELD, AN INDENTATION WAS NOTED AT APPROXIMATELY THE 84 CM AREA. THE COMPLAINT "THE BALLOON WAS BROKEN" WAS CONFIRMED; HOWEVER, THERE ARE NO INDICATIONS THAT THIS IS RELATED TO THE MANUFACTURING PROCESS. THE CAUSE OF THE BALLOON LEAKAGE COULD NOT BE DETERMINED WITH ANY CERTAINTY; DEVICE HANDLING MAY HAVE CONTRIBUTED TO THE DAMAGE. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WAS BROKEN DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273271 SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 744HF75 59207403

    Patients

    Seq Age Sex Outcome Treatment
    1