BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)

    MDR report key: 2861418 · Received December 7, 2012

    Report

    Report Number
    2015691-2012-18777
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 13, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K822723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BIPOLAR PACING CATHETER WITHOUT ANY ATTACHED COMPONENTS WAS RETURNED FOR EVALUATION. NO INTRODUCER OR SYRINGE WAS RETURNED. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3CC AIR AND THE BALLOON REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. CONTINUITY TESTING WAS PERFORMED ON THE DISTAL AND THE PROXIMAL ELECTRODES AND THERE WERE NO OPEN, INTERMITTENT OR SHORT CONDITIONS OBSERVED. NO VISIBLE DAMAGE TO THE CATHETER BODY, BALLOON LATEX, OR BALLOON WINDINGS WAS FOUND. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION AND WITH THE UNAIDED EYES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE COMPLAINT COULD NOT BE CONFIRMED DURING THE EVALUATION. NO INDICATION OF A MANUFACTURING DEFECT WAS NOTED DURING THE ANALYSIS. IT COULD NOT BE DETERMINED IF ANY CLINICAL OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE ON THE FIRST DAY OF USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA) PACING CATHETER DYG EDWARDS LIFESCIENCES, PR D97120F5 59307063

    Patients

    Seq Age Sex Outcome Treatment
    1