BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

    MDR report key: 7094845 · Received December 7, 2017

    Report

    Report Number
    3011706110-2017-00102
    Event Type
    Death
    Date Received
    December 7, 2017
    Report Date
    December 6, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K142084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO ATRICURE FOR EVALUATION AS THERE WAS NO COMPLAINT OF A DEVICE DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    THROUGH A CONVERSATION ON (B)(6) 2017, A COMPANY REPRESENTATIVE CAME TO KNOW OF A PATIENT WHO ON (B)(6) 2017, HAD A HYBRID ABLATION SURGICAL PROCEDURE SIMULTANEOUS WITH EP CATHETER ABLATION. THE SURGICAL ABLATION WAS DONE FIRST WITH THE SURGEON GETTING SUBXIPHOID ACCESS AND THE EP DOCTOR DID THE EP CATHETER ABLATION TO FOLLOW VIA ACCESS THROUGH THE GROIN USING THE BIOSENSE CONTACT FORCE ABLATION CATHETER WITH THE PATIENT BEING HEPARINIZED WITH AN UNKNOWN AMOUNT. APPROXIMATELY 2 WEEKS POST PROCEDURE, THE PATIENT PRESENTED AT A DIFFERENT FACILITY WITH CHEST PAIN WHERE APPARENTLY, AIR WAS FOUND IN THE PERICARDIUM. THE PATIENT WAS THEN TRANSFERRED TO THE FACILITY WHERE THE ORIGINAL PROCEDURE HAD TAKEN PLACE AND A CONTRAST STUDY WAS DONE. AN ATRIOESOPHAGEAL FISTULA WAS DETERMINED AND THE PATIENT WENT DIRECTLY FOR SURGERY. ONCE IN SURGERY, THEY COULD NOT FIND ANYTHING TO REPAIR. THE PATIENT DIED A FEW DAYS LATER. THE EXACT DATE OF THE PATIENT EXPIRING IS NOT KNOWN AND AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876240 EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX OCL ATRICURE, INC. CDK-1413 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CSK-6130, CSK-2000, BIOSENSE CONTACT FORCE CATHETE