BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

    MDR report key: 3132650 · Received May 29, 2013

    Report

    Report Number
    2015691-2013-20179
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 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 WAS RECEIVED WITH AN ATTACHED MONOJECT 1.3 LIMITED VOLUME SYRINGE. THE BALLOON INFLATED BUT FAILED TO MAINTAIN ITS INFLATION DUE TO LEAKAGE FROM A GAP BETWEEN PROXIMAL ELECTRODE AND CATHETER BODY BLOOD WAS OBSERVED UNDER THE BALLOON. THE BALLOON LATEX APPEARED SLIGHTLY DETERIORATED. CONTINUITY TESTING WAS PERFORMED ON THE DISTAL AND PROXIMAL ELECTRODES AND THERE WERE NO OPEN, INTERMITTENT, OR SHORT CONDITIONS OBSERVED. THERE WAS NO VISIBLE INCONSISTENCE OBSERVED FROM THE WINDINGS AND RETURNED SYRINGE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. CUSTOMER REPORT OF PACING ISSUE WAS NOT CONFIRMED; HOWEVER, BALLOON INFLATION ISSUE WAS CONFIRMED. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE IF THE ROOT CAUSE FOR THE GAP BETWEEN THE PROXIMAL ELECTRODE AND CATHETER BODY FOUND DURING THE EVALUATION 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." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235292 SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION ELECTRODE, PACEMAKER, TEMPORARY LDF EDWARDS LIFESCIENCES, PR PE075F5 59330818

    Patients

    Seq Age Sex Outcome Treatment
    1