BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)

    MDR report key: 3193125 · Received June 27, 2013

    Report

    Report Number
    2015691-2013-20443
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K822723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BIPOLAR PACING CATHETER WAS RECEIVED WITH A 1.3CC MONOJECT LIMITED VOLUME SYRINGE. THERE WAS NO INTRODUCER RECEIVED. THERE WAS NO VISIBLE DAMAGE OR DEFECT OBSERVED ON THE CATHETER BODY, BALLOON, WINDINGS, OR THE RETURNED SYRINGE. THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY WITH 1.3 CC OF AIR AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. CONTINUITY TESTING CONFIRMED A FULL OPEN CONDITION OF THE PROXIMAL CIRCUIT. HOWEVER, THE DISTAL ELECTRODE CIRCUIT WAS FOUND TO BE CONTINUOUS. A CUT DOWN OF THE CATHETER BODY WAS PERFORMED JUST PROXIMAL OF THE PROXIMAL ELECTRODE TO EXPOSE THE PACING LEAD WIRES. THE PROXIMAL LEAD WIRE WAS FOUND BROKEN 0.1¿ (OR 2.5 MM) PROXIMAL FROM THE PROXIMAL ELECTRODE. IT WAS FOUND THAT THE CIRCUIT WAS CONTINUOUS BETWEEN THE PROXIMAL ELECTRODE AND PROXIMAL CONNECTOR PIN WHEN TESTED AROUND THE BROKEN SECTION OF THE WIRE; THUS THE PACING DIFFICULTY APPEARS TO BE RELATED TO THE BREAK IN THE WIRE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE REPORT OF PACING FAILURE WAS CONFIRMED. AN INVESTIGATION WAS OPENED TO DETERMINE THE CAUSE OF THE WIRE DAMAGE AND IMPLEMENT ANY NECESSARY ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE DURING USE¿. ANOTHER CATHETER WAS USED AND THERE WAS NO FURTHER PROBLEM WITH THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294297 SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA) CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR D97120F5 59446334

    Patients

    Seq Age Sex Outcome Treatment
    1