BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCOMBO

    MDR report key: 1020381 · Received March 17, 2008

    Report

    Report Number
    1020381
    Event Type
    Malfunction
    Date Received
    March 17, 2008
    Date of Event
    March 8, 2008
    Report Date
    March 17, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS FLUSHED BUT HAD NOT BEEN INSERTED INTO THE PATIENT. THE BALLOON WAS TESTED. THE BALLOON WOULD NOT INFLATE. THE SYRINGE WAS REMOVED, PULLED BACK, AND RE-ATTACHED TO THE CATHETER. ANOTHER ATTEMPT WAS MADE TO INFLATE THE BALLOON WITH NO SUCCESS. THE SYRINGE WAS CHANGED AND A THIRD ATTEMPT TO INFLATE THE BALLOON WAS MADE WITH NO SUCCESS. THE DEVICE WAS THEN REMOVED FROM SERVICE. THE DEVICE WAS NEVER USED ON THE PATIENT. NO PATIENT HARM NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCOMBO CATHETER, SWAN-GANZ, CCO DYG EDWARDS LIFESCIENCES, LLC * 58420135

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR