BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE HEART LASER CO2 TMR SYSTEM (P950015)

    MDR report key: 3423215 · Received September 8, 2013

    Report

    Report Number
    9680239-2013-00001
    Event Type
    Injury
    Date Received
    September 8, 2013
    Date of Event
    August 7, 2013
    Report Date
    September 6, 2013
    Manufacturer
    NOVADAQ TECHNOLOGIES,=INC.
    Product Code
    MNO
    PMA / PMN Number
    P950015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER DEVICE AND EVENT INFORMATION IS BEING SOUGHT FROM THE DISTRIBUTOR AND THE HOSPITAL. A QUESTIONNAIRE WAS IMMEDIATELY SEN TO THE SITE UPON RECEIPT OF COMPLAINT BY NOVADAQ. THE DATE, NO RESPONSE HAS BEEN RECEIVED FOR THE QUESTIONNAIRE. NOVADAQ IS CONTINUING EFFORTS TO RECEIVE FURTHER INFORMATION. IT IS KNOWN BY NOVADAQ THE HEART LASER CO2 TMR DID NOT MALFUNCTION. THE DEVICE FUNCTIONED CORRECTLY AND AS INTENDED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT DESCRIPTION IS PROVIDED VERBATIM FROM THE INITIAL COMPLAINT. "SURGERY WAS SCHEDULED TO BE A REDO CABG WITH TMR LASER THERAPY. DURING PREOP, THE SURGEON AND CARDIOLOGIST MADE THE DETERMINATION TO FOREGO THE CABG PROCEDURE AND INSTEAD BEFORE A STAND-ALONE TMR LASER PROCEDURE. THE PROCEDURE PROCEEDED AND THE TNR LASER WAS ADMINISTERED WITHOUT ISSUE OR INCIDENT. AS THE PATIENT WAS RECOVERING ON THE TABLE IN THE OPERATING ROOM, HE EXPERIENCED A SIGNIFICANT ARRHYTHMIA AND NEEDED TO BE MANAGED MEDICALLY. EMERGENTLY, THE CARDIAC TEAM PLACED AN ARROW IABP INTO THE PATIENT. THE PATIENT STABILIZED AND WAS THEN TRANSPORTED TO THE PACU. DURING TRANSPORT, THE PATIENT EXPERIENCED MULTIPLE ARRHYTHMIAS AND CODED TWICE. THE PATIENT WAS RUSHED BACK TO THE OPERATING ROOM UNDER MANUAL CHEST COMPRESSIONS AND THEY EMERGENTLY OPENED THE PATIENT'S CHEST. ULTIMATELY, THE PATIENT RECEIVED AN ABIOMED BIVENTRICULAR ASSIST DEVICE AND WOULD LIKELY BE TRANSFERRED TO ANOTHER CENTER." NOVADAQ IS ATTEMPTING TO ACQUIRE FURTHER INFORMATION FROM THE REPORTING HOSPITAL. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445197 THE HEART LASER CO2 TMR SYSTEM (P950015) NONE MNO NOVADAQ TECHNOLOGIES,=INC. CO2 TMR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R