BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 4088938 · Received September 15, 2014

    Report

    Report Number
    2950727-2014-00019
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    July 1, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CASE REPORT FORM REPORT RECEIVED FROM THE ANGINA RELIEF REGISTRY, THE PATIENT UNDERWENT A CABG+TMR PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 18 CHANNELS PLACED. ON (B)(6) 2014 THE PATIENT NOTICED THE INCISION TO BE OPEN AND BLEEDING WITH A FOUL SMELL. A REVIEW OF MANUFACTURING AND INSPECTION RECORDS FROM THE LOT OF THIS DEVICE WAS PERFORMED AND ALL COMPONENTS WERE FOUND TO MEET SPECIFICATION. THIS COMPLAINT SUGGESTS THAT WHILE THE PATIENT PRESENTED WITH A POSSIBLE ADVERSE EVENT FOLLOWING THE PROCEDURE, IT DOES NOT APPEAR TO BE RELATED TO THE HANDPIECE. THE INSTRUCTIONS FOR USE (IFU) WARN, "INSPECT SEALED, STERILE PACKAGE BEFORE OPENING. PRODUCT IS STERILE ONLY IN UNOPENED, UNDAMAGED PACKAGE. IF PACKAGE IS OPENED OR DAMAGED, OR IF SEAL IS BROKEN, CONTENTS MAY NOT BE STERILE AND MAY CAUSE INFECTION IN THE PATIENT." ACCORDING TO DOCUMENTATION, ALL AVAILABLE RECORDS SHOW THE HANDPIECES WERE CORRECTLY ASSEMBLED FROM APPROVED COMPONENTS AND WERE INSPECTED TO SPECIFICATIONS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE. THE INSTRUCTIONS FOR USE PROVIDE ADEQUATE WARNINGS AND PRECAUTIONS. .

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW UP 1 WAS FOR A COMPLAINT UNRELATED TO COMPLAINT (B)(4). THIS MEDWATCH CONTAINS THE CORRECT INFORMATION FOR COMPLAINT (B)(4). ACCORDING TO THE CASE REPORT FORM, THE PATIENT WAS RE-HOSPITALIZED FOR A MINOR SUPERFICIAL STERNAL INFECTION TREATED SUCCESSFULLY WITH ANTIBIOTICS AND LOCAL WOUND CARE. THE TMR PROCEDURE TOOK PLACE ON (B)(6) 2014, AND THE PATIENT WAS RE-HOSPITALIZED 20 DAYS LATER ON (B)(6) 2014 FOR THE STERNAL INFECTION. A REVIEW OF MANUFACTURING AND INSPECTION RECORDS FROM THE LOT OF THIS DEVICE WAS PERFORMED AND ALL COMPONENTS WERE FOUND TO MEET SPECIFICATION. THIS COMPLAINT SUGGESTS THAT WHILE THE PATIENT PRESENTED WITH A POSSIBLE ADVERSE EVENT FOLLOWING THE PROCEDURE, IT DOES NOT APPEAR TO BE RELATED TO THE HANDPIECE. THE INSTRUCTIONS FOR USE (IFU) WARN, "INSPECT SEALED, STERILE PACKAGE BEFORE OPENING. PRODUCT IS STERILE ONLY IN UNOPENED, UNDAMAGED PACKAGE. IF PACKAGE IS OPENED OR DAMAGED, OR IF SEAL IS BROKEN, CONTENTS MAY NOT BE STERILE AND MAY CAUSE INFECTION IN THE PATIENT." ACCORDING TO DOCUMENTATION, ALL AVAILABLE RECORDS SHOW THE HANDPIECES WERE CORRECTLY ASSEMBLED FROM APPROVED COMPONENTS AND WERE INSPECTED TO SPECIFICATIONS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE. THE INSTRUCTIONS FOR USE PROVIDE ADEQUATE WARNINGS AND PRECAUTIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE CASE REPORT FORM, THE PATIENT WAS RE-HOSPITALIZED FOR A MINOR SUPERFICIAL STERNAL INFECTION TREATED SUCCESSFULLY WITH ANTIBIOTICS AND LOCAL WOUND CARE. THE TMR PROCEDURE TOOK PLACE ON (B)(6) 2014, AND THE PATIENT WAS RE-HOSPITALIZED 20 DAYS LATER ON (B)(6) 2014 FOR THE STERNAL INFECTION.

    Description of Event or Problem · 1

    ACCORDING TO THE CASE REPORT FORM, THE PATIENT WAS RE-HOSPITALIZED FOR A MINOR SUPERFICIAL STERNAL INFECTION TREATED SUCCESSFULLY WITH ANTIBIOTICS AND LOCAL WOUND CARE. THE TMR PROCEDURE TOOK PLACE ON (B)(6) 2014, AND THE PATIENT WAS RE-HOSPITALIZED 20 DAYS LATER ON (B)(6) 2014 FOR THE STERNAL INFECTION.

    Description of Event or Problem · 1

    THE PATIENT HAD A TMR PROCEDURE ON (B)(6) 2014. ON (B)(6) 2014 THE PATIENT NOTED INCISION OPEN AND BLEEDING WITH A FOUL SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568485 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARISZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-04032-10

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other