BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 1883616 · Received October 26, 2010

    Report

    Report Number
    2015691-2010-14258
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LDF
    PMA / PMN Number
    K813521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WAS DISCARDED AT THE HOSPITAL AND WE ARE UNABLE TO EVALUATE THE DEVICE FOR POSSIBLE ROOT CAUSE. THE LOT NUMBER WAS REPORTED AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE DEVICE MET SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO PACE DURING USE. ANOTHER CATHETER WAS USED. THE DEVICE WAS DISCARDED AT THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION BIPOLAR PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE074F5 58752186

    Patients

    Seq Age Sex Outcome Treatment
    1