BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3922275 · Received July 9, 2014

    Report

    Report Number
    2015691-2014-01560
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE MODEL# 746HF8 CATHETER FOR EXAMINATION. THE BALLOON WAS FOUND TO BE RUPTURED AT THE CENTER AREA OF LATEX AROUND CIRCUMFERENCE AND THE RUPTURED EDGES DID NOT APPEAR TO MATCH UP, INDICATING A GAP OF MISSING LATEX. SEVERAL CRACKS WERE FOUND THROUGHOUT THE SURFACE THE BALLOON, INDICATING LATEX DETERIORATION. DETERIORATION IS "A CONDITION USUALLY CASED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE¿. ALL OTHER THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO OTHER VISUAL DAMAGE, CONTAMINATION, OR OTHER ABNORMALITIES FOUND ON CATHETER. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    THE BALLOON DISINTEGRATED AFTER PUSHING IT THROUGH THE SWAN SLEEVE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400174 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 746HF8 59454217

    Patients

    Seq Age Sex Outcome Treatment
    1