BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIGO REMOTE CATHETER SYSTEM

    MDR report key: 3775741 · Received April 14, 2014

    Report

    Report Number
    3008365050-2014-00001
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 25, 2014
    Manufacturer
    CATHETER ROBOTICS
    Product Code
    DXX
    PMA / PMN Number
    K122488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    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 REPORT THIS EVENT AS RELATED TO AMIGO, BUT RELATEDNESS COULD NOT BE RULED OUT. A CATHETER ROBOTICS REPRESENTATIVE WAS PRESENT DURING THE CASE, AND CONFIRMED THAT NO AMIGO MALFUNCTION OCCURRED. PERICARDIAL EFFUSION IS A KNOWN RISK ASSOCIATED WITH CATHETER ABLATION PROCEDURES AND IS DOCUMENTED IN THE LABELING FOR BOTH AMIGO AND ABLATION CATHETERS. LITERATURE INDICATES PERICARDIAL EFFUSION IS ONE OF THE MOST FREQUENTLY OBSERVED COMPLICATIONS REPORTED IN ATRIAL FIBRILLATION ABLATION PROCEDURES, OCCURRING IN 16% PROCEDURES (B)(6). THERE IS NO EVIDENCE THAT USE OF AMIGO IMPACTS THIS INCIDENCE.

    Description of Event or Problem · 1

    AMIGO WAS USED WITH AN EZ STEER THERMOCOOL CATHETER TO PERFORM AN AF ABLATION PROCEDURE (PULMONARY VEIN ISOLATION). FOLLOWING A SUCCESSFUL ABLATION, THE PHYSICIAN PERFORMED AN ATRIAL FLUTTER ABLATION MANUALLY (WITHOUT AMIGO). AT THE END OF THE PROCEDURE A SMALL PERICARDIAL EFFUSION WAS DETECTED WITH INTRACARDIAC ECHO THAT WAS USED DURING THE PROCEDURE. THE PHYSICIAN REVERTED HEPARIN AND PERFORMED DRAINAGE. ABOUT 70ML OF FRESH RED BLOOD WAS DRAINED. AFTER EVACUATION THERE WAS NO SEPARATION AND BLEEDING STOPPED. A DRAIN WAS PLACED AND SUBSEQUENTLY REMOVED ON (B)(6). AN ECHO PERFORMED ON (B)(6). INDICATED THAT THE SMALL EFFUSION WAS NOT HEMODYNAMICALLY SIGNIFICANT. THERE WAS A SUBSEQUENT ONSET OF A LOW-GRADE FEVER AND ELEVATION OF INFECTIOUS PARAMETERS, AND IBUPROFEN WAS ADMINISTERED. HEPARIN WAS ALSO ADMINISTERED IN REDUCED DOSAGE. THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 IN STABLE CONDITION. THIS EVENT WAS INITIALLY REPORTED TO MANUFACTURER BY A COMPANY EMPLOYEE AND THE PHYSICIAN PROVIDED FURTHER DETAILS AND MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228109 AMIGO REMOTE CATHETER SYSTEM AMIGO DXX CATHETER ROBOTICS 1012

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention EZ STEER THERMOCOOL CATHETER