BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 3903313 · Received June 30, 2014

    Report

    Report Number
    2015691-2014-01489
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    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 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.

    Additional Manufacturer Narrative · 1

    ONE PACING CATHETER WITH ATTACHED MONOJECT 1.3 ML LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. NO RESISTANCE WAS FELT DURING INJECTING AIR. NO VISIBLE DAMAGE OR DETERIORATION TO THE BALLOON LATEX OR BALLOON WINDING SITES WAS FOUND. THE BALLOON DEFLATED WITHIN SPECIFICATION WITHIN 1 SECOND WITHOUT THE SYRINGE ATTACHED. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE TO THE CATHETER OR SYRINGE WAS OBSERVED. BALLOON INFLATION TEST WAS PERFORMED USING RETURNED SYRINGE WITH 1.3 CC AIR. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. CUSTOMER REPORT THAT BALLOON "WAS UNABLE TO DEFLATE¿ WAS NOT CONFIRMED. THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. IT IS UNKNOWN IF PROCEDURAL FACTORS OR DEVICE HANDLING MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO DEFLATE THE BALLOON BEFORE USE. IT IS UNKNOWN IF THE INFLATION SYRINGE WAS REMOVED FROM THE GATE VALVE OR NOT." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379791 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE074F5

    Patients

    Seq Age Sex Outcome Treatment
    1