BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

    MDR report key: 3071569 · Received April 22, 2013

    Report

    Report Number
    2015691-2013-19880
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    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 BIPOLAR PACING CATHETER WITH ATTACHED MONOJECT 1.3CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. NO INTRODUCER WAS RETURNED WITH THE CATHETER. CONTINUITY TESTING FOUND THAT A SHORT CONDITION OCCURRED IN THE Y-ADAPTOR BETWEEN THE PROXIMAL AND DISTAL LEADWIRES. NO OPEN OR SHORT CONDITIONS WERE OBSERVED IN THE LEADWIRES BETWEEN THE DISTAL PORTION OF THE Y-ADAPTOR AND THE ELECTRODES. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. NO VISIBLE DAMAGE TO THE CATHETER BODY, BALLOON, WINDINGS, OR RETURNED SYRINGE WAS OBSERVED. CONTINUITY TESTING WAS DONE BY CONNECTING ONE TEST LEAD OF A MULTIMETER TO AN ELECTRODE CONNECTOR PIN AND THE OTHER LEAD TO THE RELATED ELECTRODE. RESISTANCE WAS MEASURED WITH DIGITAL MULTIMETER. BALLOON INFLATION TESTING WAS PERFORMED USING RETURNED SYRINGE WITH 1.3CC AIR BY HOLDING THE BALLOON UNDER WATER. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE CUSTOMER REPORT OF PACING DIFFICULTY WAS CONFIRMED DURING THE EVALUATION. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE IF THE ROOT CAUSE IS RELATED TO THE MANUFACTURING PROCESS AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE DURING USE." NO PATIENT COMPLICATIONS OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172238 SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE075F5 59351241

    Patients

    Seq Age Sex Outcome Treatment
    1