BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATRICURE BIPOLAR SYSTEM

    MDR report key: 5077653 · Received September 11, 2015

    Report

    Report Number
    3003502395-2015-00034
    Event Type
    Death
    Date Received
    September 11, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 13, 2015
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K101174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED FOR EVALUATION HOWEVER DEVICE HISTORY RECORD REVIEWED AND NO NON-CONFORMANCE OR RE-WORK NOTED DURING MANUFACTURING PROCESS THAT WOULD BE RELATED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MIS PROCEDURE, THAT WHEN THE SURGEON PLACED THE CLAMP AROUND THE LEFT PULMONARY VEINS AND CLOSED THE CLAMP, HE NOTICED BRIGHT RED BLOOD. HE OPENED THE PATIENT'S CHEST TO GAIN CONTROL OF THE BLEEDING. SURGEON THINKS THERE MUST HAVE BEEN TISSUE ATTACHED TO THE LEFT ATRIUM THAT WAS ALSO CONNECTED TO THE PULMONARY VEIN. WHEN HE CLOSED THE CLAMP (EML), THE LEFT ATRIUM COMPRESSED AND THE TISSUE CONNECTED TO THE LEFT PA PULLED ENOUGH TO TEAR THE PA. THE SURGEON MASSAGED THE HEART WHILE WAITING FOR THE PERFUSIONIST TO SET UP THE BYPASS PUMP. AFTER GETTING THE PATIENT ON PUMP AND REPAIRING THE BLEEDING, THE SURGEON COMPLETED THE LEFT SIDE OF THE MAZE PROCEDURE AND APPLIED A CLIP ON THE LEFT ATRIAL APPENDAGE. AFTER COMPLETING THE LEFT PULMONARY VEIN ISOLATION, THE PATIENT WAS TAKEN OFF PUMP, AND THE ABLATIONS WERE TESTED FOR ISOLATION BLOCK. AFTER ISOLATION BLOCK WAS CONFIRMED, THE PATIENT WAS TAKEN TO RECOVERY. ON (B)(6) 2015, ATRICURE'S DIRECTOR OF PROCEDURAL DEVELOPMENT STOPPED BY THE HOSPITAL TO FOLLOW UP ON THE PATIENT. THE SURGEON INFORMED HIM THAT THE PATIENT EXPIRED ON 08/22/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603116 ATRICURE BIPOLAR SYSTEM ISOLATOR SYNERGY CLAMP LEFT CURVE OCL ATRICURE, INC. EML2 58549

    Patients

    Seq Age Sex Outcome Treatment
    1 Death