BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 3896974 · Received June 26, 2014

    Report

    Report Number
    2015691-2014-01462
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 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

    ONE PACING CATHETER WITH MONOJECT 1.3CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. THE CATHETER WAS RECEIVED CATHETER CUT IN TWO PIECES AT 6 CM FROM THE Y-ADAPTER. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND DID NOT LEAK. CONTINUITY TESTING CONFIRMED AN INTERMITTENT CONDITION WITH THE DISTAL ELECTRODE WHEN FLEXING THE CATHETER TIP. THE PROXIMAL ELECTRODE WAS CONTINUOUS AND THERE WERE NO SHORTS OR INTERMITTENT CONDITIONS. NO VISIBLE DAMAGE TO THE RETURNED SYRINGE WAS OBSERVED. VISUAL EXAMINATIONS WERE PERFORMED WITH THE UNAIDED EYES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE CUSTOMER REPORT OF PACING DIFFICULTY WAS CONFIRMED. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE DURING USE, ALTHOUGH THE EXTERNAL PACEMAKER WAS REPLACED THREE TIMES. THE CATHETER WAS REPLACED AND POSITIONED AT WHERE THE FIRST CATHETER WAS POSITIONED, AND THEN THE PACING WAS CONFIRMED." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374178 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE074F5 59681974

    Patients

    Seq Age Sex Outcome Treatment
    1