BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 3961405 · Received July 28, 2014

    Report

    Report Number
    2015691-2014-01707
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    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

    NO PRODUCT WAS RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE HOSPITAL. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF DAMAGES OR DEFECTS EXISTED ON THE PRODUCT. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PROXIMAL ELECTRODE GOT DETACHED FROM THE Y-ADAPTOR DURING USE." THE PROBLEM OCCURRED SOMETIME IN (B)(6) 2014, BUT THE SPECIFIC OCCURRENCE DATE IS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437755 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE074F5

    Patients

    Seq Age Sex Outcome Treatment
    1