BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1982831 · Received February 9, 2011

    Report

    Report Number
    2015691-2011-14758
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 11, 2010
    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 LEAKING" WAS CONFIRMED. THE BALLOON FAILED TO INFLATE AS THE LATEX WAS FULLY DETACHED FROM BOTH THE PROXIMAL AND DISTAL BONDS. RESIDUAL ADHESIVE WAS VISIBLE AT BOTH THE PROXIMAL AND DISTAL BOND SITES. THERE DID NOT APPEAR TO BE ANY MISSING LATEX. THE CONTAMINATION SHIELD, SYRINGE AND INTRODUCER WERE NOT RETURNED. ALL THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE. THERE WAS NO VISIBLE DAMAGE TO CATHETER BODY. ALTHOUGH THE COMPLAINT WAS CONFIRMED, 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON AT THE PROXIMAL END WAS FOUND LEAKING BEFORE 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 THERMODILUATION CATHETER DYG EDWARDS LIFESCIENCES, PR 831HF75 58832736

    Patients

    Seq Age Sex Outcome Treatment
    1