BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS

    MDR report key: 1951078 · Received January 6, 2011

    Report

    Report Number
    2015691-2011-14619
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K001063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A SITE VISIT WAS CONDUCTED TO DISCUSS THE ISSUE WITH THE PHYSICIAN, WHO IS A CARDIAC ANESTHESIOLOGIST. THE PHYSICIAN COMMENTED THAT THE LOCKING MECHANISM ON THE CONTAMINATION SHIELD OF THE LATEX-FREE SWAN-GANZ CATHETERS IS INADEQUATE AND HE WAS ABLE TO DEMONSTRATE THE LOOSENESS HE WAS EXPERIENCING BY TIGHTENING DOWN THE TUOHY-BORST TYPE ADAPTER ON THE DISTAL END OF THE CONTAMINATION SHIELD AND PULLING ON THE SWAN-GANZ CATHETER. HE ALSO COMMENTED THAT IF HE EXCESSIVELY TIGHTENS THE ADAPTER, IT MAY AFFECT THE FLOW RATES THROUGH THE CATHETER LUMEN. DURING THE PROCEDURE ASSOCIATED WITH THIS EVENT, HE USED THE 9FR AUTO/HIGH FLOW INTRODUCER (PN 597260) PROVIDED WITH THE C146 SYNTHETIC BALLOON CATHETER (INTRO KIT I505BF9NL), WHICH IS THE SAME INTRODUCER THAT IS USED WITH STANDARD SWAN-GANZ CATHETERS (CDP KIT S507BF09). THE COMPLAINT ISSUE COULD BE CONFIRMED DURING DISCUSSION WITH THE PHYSICIAN; HOWEVER, THERE ARE NO INDICATIONS THAT THE PRODUCT IS OUT OF SPECIFICATION. IT WAS NOTED THAT THE SYNTHETIC CATHETERS DO HAVE A SMALLER DIAMETER THAN THE LATEX CATHETERS AND THE ISSUE OF THE CATHETER/CONTAMINATION SHIELD FIT WILL BE FURTHER EVALUATED. ADDITIONALLY, OTHER POSSIBLE KIT CONFIGURATIONS WILL ALSO BE EVALUATED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP SITE VISIT WAS CONDUCTED TO DISCUSS ALTERNATIVES FOR THE NON-LATEX BALLOON SWAN-GANZ INTRODUCER KIT WITH THE CARDIAC ANESTHESIOLOGIST WHO FILED THE COMPLAINT. THE CONVERSATION INCLUDED THE POSSIBILITY OF USING THE INTRODUCER WITH THE MANUAL LOCKING MECHANISM AS OPPOSED TO THE AUTOMATIC ONE THEY CURRENTLY HAVE IN THEIR KITS. THE ANESTHESIOLOGIST TESTED THIS ON SAMPLE CATHETERS AND FELT IT WAS A GREAT IMPROVEMENT OVER THEIR CURRENT DEVICES. HE DID NOTE THAT THE SIDEARM WAS SMALLER ON THE MANUAL SAMPLE WHICH MAY BE A PROBLEM IN CERTAIN CASES REQUIRING LARGE INFUSION CAPACITIES, SUCH AS LIVER TRANSPLANTS. AN EDWARDS ENGINEER PROVIDED THE ANESTHESIOLOGIST WITH SOME BACKGROUND ON THE LATEX-FREE SWAN-GANZ AND THAT OUR TESTING DEMONSTRATED THAT THE BALLOON ON THIS DEVICE WAS SENSITIVE TO DAMAGE WHEN PLACED THROUGH THE INTRODUCER. AS A RESULT, EDWARDS WON'T RECOMMEND THIS ALTERNATIVE INTRODUCER TO USE WITH THE LATEX-FREE SWANS. EDWARDS COMMITTED TO INVESTIGATING WHETHER THE INTRODUCER WITH THE MANUAL LOCK IS AVAILABLE IN A 9 FR AND IF IT COULD BE ORDERED WITH THE LARGER BORE SIDEARM. IT IS NOT YET KNOWN IF THIS ISSUE CAN BE RESOLVED WITH THE LATEX FREE DEVICE AS THIS MAY REQUIRE EXTENSIVE TESTING AND POSSIBLE REGULATORY FILINGS. EDWARDS WILL COMMUNICATE ANESTHESIOLOGIST CONCERNS BACK TO MANAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF A LATEX-FREE SWAN-GANZ CATHETER, THE CATHETER PULLED BACK INTO THE PATIENT'S RIGHT VENTRICLE AND CAUSED AN EPISODE OF VENTRICULAR TACHYCARDIA AFTER THE PATIENT HAD BEEN DELIVERED TO THE ICU. THE PHYSICIAN RETURNED TO REPOSITION THE CATHETER AND NO PATIENT INJURY OCCURRED. AS REPORTED, THE PHYSICIAN HAD TAKEN EXTRA MEASURES TO SECURE THE CATHETER BY TAPING IT TO THE PATIENT'S FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS CATHETER/INTRODUCER COMBO SYSTEM DYG EDWARDS LIFESCIENCES, PR K9FC146F7

    Patients

    Seq Age Sex Outcome Treatment
    1