BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMIGO REMOTE CATHETER SYSTEM

    MDR report key: 3873839 · Received June 5, 2014

    Report

    Report Number
    3008365050-2014-00002
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    April 4, 2013
    Report Date
    May 9, 2014
    Manufacturer
    CATHETER ROBOTICS, INC.
    Product Code
    DXX
    PMA / PMN Number
    K122488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6), WHERE USE OF AMIGO WITH ABLATION CATHETERS IS CONSISTENT WITH THE APPROVED INDICATIONS FOR USE. THE PHYSICIAN DID NOT INITIALLY REPORT THIS EVENT TO CATHETER ROBOTICS FOR TWO REASONS: THE PHYSICIAN DID NOT FEEL THE EVENT WAS RELATED TO AMIGO. THERE WAS NO DEVICE MALFUNCTION NOTED. IN ADDITION, THE ENTIRE PROCEDURE WAS MONITORED WITH ICE BY A DEDICATED OPERATOR (THE CASE WAS RECORDED IN FULL IN ORDER TO PRODUCE A VIDEO) AND NO ODD CATHETER TRAJECTORIES OR CHAMBER DISTORTION EXPECTED IF EXCESSIVE OR UNEXPECTED FORCE ON THE CATHETER WERE NOTED. THIS IS A KNOWN COMPLICATION ASSOCIATED WITH THIS CATHETER (REPORTED BY (B)(6) AT (B)(6) 2013 SCIENTIFIC SESSION). CONSEQUENTLY, THE PHYSICIAN REPORTED THE EVENT TO THE CATHETER MFR AND LOCAL AUTHORITIES AS A CATHETER RELATED COMPLICATION.

    Description of Event or Problem · 1

    A SUCCESSFUL PULMONARY VEIN ISOLATION FOR ATRIAL FIBRILLATION WAS PERFORMED USING AMIGO WITH THE EZ STEER THERMOCOOL SF CATHETER (IRRIGATED 3.5MM) ON (B)(6) 2013. NO COMPLICATIONS WERE NOTED AT THAT TIME, AND THE PT WAS DISCHARGED THE FOLLOWING MORNING. THE PT WAS HOSPITALIZED ON (B)(6) 2013 WITH TRANSIENT LEFT SUPERIOR HEMIPARESIS, CHEST PAIN AND PALPITATIONS. THE PT WAS ADMITTED TO THE STROKE UNIT, AND AN ATRIO-ESOPHAGEAL FISTULA (AEF) WAS DISCOVERED ON TRANS-ESOPHAGEAL ECHOCARDIOGRAM (TEE) AND AN ESOPHAGEAL ENDOSCOPY CONFIRMED A LARGE, DEEP ULCER CONSISTENT WITH AEF ON THE LEFT ANTERIOR WALL OF THE MID THIRD OF THE ESOPHAGUS. HOWEVER, BY THE TIME THE FISTULA WAS CONFIRMED, THE SURGEON WAS NOT ABLE TO OPERATE DUE TO THE PT'S HEMODYNAMIC DETERIORATION. AN INTRAESOPHAGEAL STENT WAS PLACED THE PT DIED TWO DAYS LATER DUE TO REFRACTORY SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329587 AMIGO REMOTE CATHETER SYSTEM AMIGO DXX CATHETER ROBOTICS, INC. 1012

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death BIOSENSE WEBSTER EZ STEER THERMOCOOL SF CATHETER