BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 4032251 · Received August 25, 2014

    Report

    Report Number
    2950727-2014-00017
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    June 8, 2014
    Report Date
    August 18, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH THE ANGINA RELIEF REGISTRY. A (B)(6) PATIENT UNDERWENT A TMR+CABG PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 20 CHANNELS PLACED. THE PATIENT WAS RE-HOSPITALIZED FOR PLEURAL EFFUSION ON (B)(6) 2014. THE PATIENT WAS ANGINA FREE 30 DAYS POST TMR. A REVIEW OF MANUFACTURING AND INSPECTION RECORDS FROM THE LOT OF THIS DEVICE WAS PERFORMED AND ALL COMPONENTS WERE FOUND TO MEET SPECIFICATION. PLEURAL EFFUSION IS A COMMON ADVERSE EVENT AFTER CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURES WITH OR WITHOUT ADJUNCTIVE TMR. ADEQUATE PRECAUTIONS AND WARNINGS ARE PRESENT IN THE PRODUCT'S INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PATIENT UNDERWENT A CABG+TMR PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 20 CHANNELS PLACED. PATIENT ALSO HAD LIMA ANASTOMOSED TO THE LAD. ON (B)(6) 2014, THE PATIENT WAS REHOSPITALIZED FOR PLEURAL EFFUSION

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PATIENT UNDERWENT A CABG+TMR PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 20 CHANNELS PLACED. PATIENT ALSO HAD LIMA ANASTOMOSED TO THE LAD. ON (B)(6) 2014 THE PATIENT WAS REHOSPITALIZED FOR PLEURAL EFFUSION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512408 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARLIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-04009

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other