BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

    MDR report key: 3061343 · Received April 16, 2013

    Report

    Report Number
    2015691-2013-19824
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 21, 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 1.3 CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. 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, WINDINGS OR RETURNED SYRINGE WAS FOUND. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION AND WITH THE UNAIDED EYES. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE DURING USE." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    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
    163753 SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE075F5

    Patients

    Seq Age Sex Outcome Treatment
    1