BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3734788 · Received April 8, 2014

    Report

    Report Number
    2950727-2014-00008
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    February 18, 2014
    Report Date
    March 31, 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

    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. THE PATIENT UNDERWENT TMR+CABG PROCEDURE ON (B)(6) 2014. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. DURING THE FOLLOW-UP VISIT ON (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH A STERNAL INFECTION. ALL PACKAGING STEPS AND INSPECTIONS WHICH FORM AND VERIFY THE STERILE BARRIER FOR THIS PRODUCT WERE COMPLETED PER SPECIFICATIONS. NO FAILURES, REJECTIONS, OR NON-COMPLIANCES WERE NOTED IN EITHER WORK ORDER FILE THAT WOULD LEAD TO A ROOT CAUSE FOR THIS COMPLAINT. THE PATIENT HAS A HISTORY OF CONGESTIVE HEART FAILURE, DIABETES, AND PREVIOUS MYOCARDIAL INFARCTION, FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD) BEFORE AGE 55, HYPERCHOLESTEROLEMIA, AND PREVIOUS PERCUTANEOUS CORONARY INTERVENTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE PATIENT PRESENTED WITH A SUPERFICIAL STERNAL INFECTION REQUIRING HOSPITALIZATION ON (B)(6) 2014. SUPERFICIAL STERNAL WOUND INFECTIONS (SSWI) INVOLVE THE SKIN AND SUBCUTANEOUS TISSUES OF THE STERNAL REGION. THE INCIDENCE OF SSWLS FOLLOWING CARDIAC SURGERY (INCLUDING MEDIAN STERNOTOMY/CABG) VARY IN THE LITERATURE; RANGING FROM 0.24% TO 8%. MULTIPLE FACTORS HAVE BEEN SUGGESTED TO INCREASE THE RISK OF DEVELOPING POST-CABG SSWI, WITH DIABETES BEING THE MOST COMMONLY REPORTED IN THE LITERATURE. IN A STUDY BY OMRAN ET AL (2007) CONSISTING OF 9,201 CABG PATIENTS, DIABETES WAS REPORTED AS A SIGNIFICANT RISK FACTOR FOR DEVELOPING SSWI (59.1% SSWI PATIENTS VS. 40.9% NON-SSWI PATIENTS WITH DIABETES; P < 0.001). RIDDERSTOLPE ET AL (2001) ALSO IDENTIFIED DIABETES AS AN INDEPENDENT RISK FACTOR IN THE DEVELOPMENT OF SUPERFICIAL STERNAL WOUND INFECTIONS IN A RETROSPECTIVE REVIEW OF 3,008 PATIENTS UNDERGOING CARDIAC SURGERY (PATIENTS WITH DIABETES: 29.4% WITH SSWI VS. 15.8% WITHOUT SSWI, P <0.001). SSWI AFTER CARDIAC SURGERY HAS BEEN A RARE YET SERIOUS REPORTED ADVERSE EVENT WITH FREQUENCIES IN THE LITERATURE MOST OFTEN <5% OF PATIENTS. CO-MORBID CONDITIONS SUCH AS DIABETES MAY PLACE PATIENTS AT HIGHER RISK FOR POST-OPERATIVE INFECTION. THE SOLOGRIP HANDPIECE DEVICE IS STERILIZED USING A VALIDATED PROCESS AND IT IS UNLIKELY TO BE RELATED TO THE REPORTED EVENT. 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 REPORT, THE PATIENT UNDERWENT TMR+CABG PROCEDURE ON (B)(6) 2014. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. DURING THE FOLLOW-UP VISIT ON (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH A SUPERFICIAL STERNAL WOUND INFECTION.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PATIENT UNDERWENT TMR+CABG PROCEDURE ON (B)(6) 2014. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. DURING THE FOLLOW-UP VISIT ON (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH A SUPERFICIAL STERNAL WOUND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211708 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-04023

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other