BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVEWIRE? ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2

    MDR report key: 4854333 · Received June 18, 2015

    Report

    Report Number
    3005188751-2015-00069
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRA
    PMA / PMN Number
    K913940
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE: 3005334138-2015-00074, 3005188751-2015-00067, 3005188751-2015-00068, 3005188751-2015-00070. FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED. A LIVEWIRE EP CATHETER WAS PLACED IN THE CORONARY SINUS. TRANSSEPTAL PUNCTURE WAS PERFORMED USING A BRK TRANSSEPTAL NEEDLE THROUGH A SWARTZ BRAIDED TRANSSEPTAL INTRODUCER. A TACTICATH QUARTZ ABLATION CATHETER WAS THEN ADVANCED THROUGH AN AGILIS NXT INTRODUCER TO PERFORM MAPPING AND ABLATION IN BOTH SIDES OF THE HEART. FOLLOWING THE PROCEDURE, A TRANSTHORACIC ECHOCARDIOGRAM REVEALED A CARDIAC PERFORATION, FOR WHICH A PERICARDIAL DRAIN WAS PLACED. THE PATIENT WAS STABLE AND RECOVERED FULLY. THERE WERE NO PERFORMANCE ISSUES NOTED WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396331 LIVEWIRE? ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2 CATHETER, STEERABLE DRA ST. JUDE MEDICAL, INC. 401940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BIOSENSE WEBSTER PENTARAY CATHETER| BRK TRANSSEPTAL NEEDLE| STOCKERT GENERATOR| TACTICATH QUARTZ ABLATION CATHETER| AGILIS NXT INTRODUCER| SWARTZ BRAIDED TRANSSEPTAL INTRODUCER