BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 2242046 · Received September 9, 2011

    Report

    Report Number
    2015691-2011-16159
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 26, 2011
    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

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. CONTINUITY TESTING CONFIRMED BOTH DISTAL AND PROXIMAL ELECTRODES WERE CONTINUOUS AND THERE WERE NO SHORTS OR INTERMITTENT CONDITIONS. NO VISIBLE DAMAGE WAS OBSERVED ON THE CATHETER BODY OR RETURNED MONOJECT 1.3 CC LIMITED VOLUME SYRINGE. VISUAL EXAMINATION WAS PERFORMED UNDER 10X MAGNIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE COMPLAINT COULD NOT BE CONFIRMED DURING THE ANALYSIS, AS THE DEVICE RESPONDED APPROPRIATELY DURING FUNCTIONAL TESTING. ALTHOUGH THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED, THERE WAS NO INDICATION OF A MANUFACTURING DEFECT NOTED DURING THE ANALYSIS. IT IS NOT KNOWN IF ANY CLINICAL 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 AFTER THE CATHETER WAS INSERTED. ANOTHER CATHETER WAS USED AND THE PROBLEM WAS SOLVED." NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE074F5 59028911

    Patients

    Seq Age Sex Outcome Treatment
    1