BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 2140042 · Received June 25, 2011

    Report

    Report Number
    2015691-2011-15789
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K813521
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 WAS PERFORMED BY CONNECTING ONE TEST LEAD OF A MULTIMETER TO AN ELECTRODE CONNECTOR PIN AND THE OTHER LEAD TO THE RELATED ELECTRODE. CONTINUITY TESTING CONFIRMED THAT THE PROXIMAL ELECTRODE HAD AN OPEN CONDITION IN THE Y-FITTING. DISTAL ELECTRODE WAS CONTINUOUS WITHOUT ANY INTERMITTENT CONDITION. NO VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY OR RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. RESISTANCE WAS MEASURED USING FLUKE MULTIMETER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE CUSTOMER REPORT OF "IT WAS UNABLE TO PACE DURING USE EVEN AT AROUND 10V OUTPUT. HOWEVER, THE CATHETER WAS NOT REPLACED SINCE THE PATIENT'S SPONTANEOUS PULSE WAS RETURNING. THERE WAS NO PROBLEM NOTED WITH THE PULSE GENERATOR" WAS CONFIRMED. AN AWARENESS TRAINING WAS CONDUCTED AT THE MANUFACTURING SITE TO PREVENT RECURRENCE OF THIS TYPE OF COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE DURING USE EVEN AT AROUND 10V OUTPUT. HOWEVER, THE CATHETER WAS NOT REPLACED SINCE THE PATIENT'S SPONTANEOUS PULSE WAS RETURNING. THERE WAS NO PROBLEM NOTED WITH THE PULSE GENERATOR." 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 DYG EDWARDS LIFESCIENCES, PR PE074F5 58971189

    Patients

    Seq Age Sex Outcome Treatment
    1