BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER W/AMC THROMBOSHIELD

    MDR report key: 3181854 · Received June 21, 2013

    Report

    Report Number
    2015691-2013-20397
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RECEIVED WITH A MONOJECT 1.5 CC VOLUME LIMITED SYRINGE. THERE WAS NO INTRODUCER OR CONTAMINATION SHIELD RETURNED WITH THE CATHETER. BALLOON TESTING WAS PERFORMED WITH THE RETURNED SYRINGE. DURING FUNCTIONAL TESTING, SOME RESISTANCE WAS FELT IN THE INFLATION LUMEN WHEN INJECTING AIR. THE BALLOON COULD BE INFLATED BUT IT WAS SLOW TO INFLATE. THERE WAS NO VISIBLE DAMAGE AND/OR DETERIORATION OBSERVED ON THE BALLOON LATEX OR BALLOON BONDING SITES. BALLOON DEFLATION TOOK MORE THAN 5 MINUTES. FURTHER EXAMINATION FOUND THE INFLATION LUMEN HAD A PARTIAL OCCLUSION. A 0.009" STYLET WIRE WAS PASSED DOWN THE INFLATION LUMEN AND THE WIRE BECAME STUCK AT THE PROXIMAL BALLOON BOND AREA. THE BALLOON LATEX WAS CUT AT THE DISTAL EDGE OF THE PROXIMAL BOND AND AN OCCLUSION WAS OBSERVED INSIDE THE INFLATION HOLE. THE INFLATION LUMEN WAS CUT OPEN TO EXPOSE THE OCCLUSION AND THE OCCLUSION WAS REMOVED FOR CHEMISTRY TESTING, WHICH FOUND THE SUBSTANCE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARED TO POLYCARBONATE-LIKE MATERIAL. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED ON THE CATHETER BODY OR RETURNED SYRINGE. THE COMPLAINT WAS CONFIRMED AND IS CONSIDERED RELATED TO THE MANUFACTURING PROCESS. AN INVESTIGATION WAS OPENED TO DETERMINE THE CAUSE OF THE COMPLAINT AND IMPLEMENT ANY NECESSARY ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT TOOK TIME UNTIL THE BALLOON INFLATED BEFORE USE." THE CATHETER WAS NOT USED AND NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282412 SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER W/AMC THROMBOSHIELD CATHETER, OXIMETER, FIBEROPTIC DQE EDWARDS LIFESCIENCES, PR 777HF8J 59454206

    Patients

    Seq Age Sex Outcome Treatment
    1