BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSENSE WEBSTER CATHETER

    MDR report key: 498278 · Received October 27, 2003

    Report

    Report Number
    498278
    Event Type
    Other
    Date Received
    October 27, 2003
    Date of Event
    May 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BEING EVALUATED IN THE EPS (ELECTROPHYSIOLOGIC STUDY) LAB FOR POSSIBLE RADIOFREQUENCY ABLATION. THE LASSO MAPPING CATHETER WAS INSERTED INTO THE LEFT SUPERIOR PULMONARY VEIN (LSPV). IN ADJUSTING THE LASSO CATHETER TOWARDS THE OS OF THE LSPV, IT WAS NOTED THE TIP OF THE CATHETER WAS STUCK ABOUT 2 CM INSIDE THE VEIN OS. THE TIP OF THE CIRCULAR MAPPING CATHETER EMBEDDED IN THE VEIN WALL. SINCE THERE WAS CONCERN OF POTENTIAL DISSECTION OF THE PULMONARY VEIN, ANTICOAGULATION WAS REVERSED AND THE CATHETER WAS REMOVED AND THE CASE ABORTED. THE CATHETER WAS REMOVED WITH TENSION AND CLOCKWISE TORQUE. IT APPEARS THAT THE TIP OF THE CATHETER WAS EXPOSED. THE PT WAS OBSERVED UNDER FLUORO FOR AN EXTENDED PERIOD OF TIME. VITAL SIGNS AND O2 SATURATION REMAINED EXCELLENT. ICE (INTRACARDIAC ECHOCARDIOGRAPHY) VISUALIZATION OF THE LSPV OS SHOWED PATENCY WITH GOOD FLOW. REPEAT CT SCAN DONE THE FOLLOWING MORNING SHOWED NO EVIDENCE OF COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CATHETER LASSO MAPPING CATHETER DRF BIOSENSE WEBSTER D7L1020RT M 527408

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other