BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD

    MDR report key: 2113763 · Received June 3, 2011

    Report

    Report Number
    2015691-2011-15682
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF "BALLOON AT THE PROXIMAL END WAS FOUND TO BE LEAKING" COULD NOT BE CONFIRMED. THE BALLOON WAS RETURNED ON THE CATHETER BODY, APPROXIMATELY 80CM FROM THE TIP. THERE WAS RESIDUAL ADHESIVE OBSERVED AT BOTH BONDS, THE LATEX WAS OBSERVED AT THE PROXIMAL BOND. THE LATEX WAS RELOCATED TO THE TIP TO OBSERVE IF THERE WAS MISSING LATEX, AND THERE DID NOT APPEAR TO BE ANY MISSING LATEX. THE LATEX APPEARED TO MATCH UP WITH RESIDUAL LATEX AT BOTH BONDS. THE CONTAMINATION SHIELD AND INTRODUCER WERE NOT RETURNED. ALL THROUGH LUMENS WERE TESTED FOR PATENCY AND LEAKAGE AS FOLLOWS: A 10CC SYRINGE WAS CONNECTED TO EACH OF THE LUMENS BEING TESTED. EACH ASSOCIATED PORT WAS COVERED WITH A FINGERTIP, ENTIRE CATHETER WAS IMMERSED IN WATER AND PRESSURIZED WITH AIR BY COMPRESSING THE SYRINGE PLUNGER. 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. THE CATHETER BODY HAD AN INDENTATION APPROXIMATELY 80CM FROM THE TIP. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 10X AND 40X MAGNIFICATION. FOLLOW UP INDICATED THAT THE BALLOON COULD HAVE MOVED DURING RE-SENDING THE CATHETER BY THE HOSPITAL STAFF DURING PACKING THE CATHETER. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED FOR BALLOON LEAKAGE. THE BALLOON WAS NOT ATTACHED AT THE CATHETER TIP; THERE IS NO EVIDENCE THAT THE DEFECT IS RELATED TO THE MANUFACTURING PROCESS, A CROSS FUNCTIONAL TEAM HAS BEEN ASSIGNED TO INVESTIGATE THESE TYPES OF OCCURRENCES IN ORDER TO DETERMINE A ROOT CAUSE AND TAKE ACTIONS AS DEEMED NECESSARY. TYPICALLY THIS WILL BE DETECTED WHILE INFLATING THE BALLOON DURING PREP. THE DIRECTIONS FOR USE INSTRUCT THE OPERATOR TO CHECK BALLOON INTEGRITY PRIOR TO USE BY INFLATING IT TO THE RECOMMENDED VOLUME IT ALSO INSTRUCTS THE OPERATOR TO CHECK FOR ASYMMETRICAL AND LEAKS BY SUBMERGING THE BALLOON IN STERILE SALINE OR WATER.

    Description of Event or Problem · 1

    IT WS REPORTED THAT THE BALLOON AT THE PROXIMAL END WAS FOUND TO BE LEAKING DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES, PR 831HF75 58832736

    Patients

    Seq Age Sex Outcome Treatment
    1