BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    MDR report key: 3945372 · Received July 2, 2014

    Report

    Report Number
    3005188751-2014-00080
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION AND SUBSEQUENT PATIENT DEATH COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE: 2030404-2014-00069, 2030404-2014-00070. DURING AN ATRIAL FLUTTER ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED AND THE PATIENT EXPIRED. AN INQUIRY STEERABLE EP CATHETER WAS PLACED IN THE CORONARY SINUS (CS) AND AN AGILIS NXT INTRODUCER WITH A SAFIRE BLU DUO ABLATION CATHETER WAS USED TO ABLATE AN ATRIAL FLUTTER LINE THROUGH THE ISTHMUS. POST-ABLATION, THE PATIENT BECAME HYPOTENSIVE AND HYPOXIC, REQUIRING CARDIOPULMONARY RESUSCITATION (CPR). A TRANSTHORACIC ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT'S CHEST WAS THEN OPENED, WHICH REVEALED A CARDIAC PERFORATION AT THE AV JUNCTION, POSTERIOR TO THE CS. THE PHYSICIAN BELIEVES THE CAUSE OF DEATH TO BE A CARDIAC PERFORATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE INVOLVED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385583 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL CATHETER, INTRODUCER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 408310

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death INQUIRY STEERABLE EP CATHETER (81104/LOT: UNK)| SAFIRE BLU DUO ABLATION CATHETER (A088109/LOT:UNK)