BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 3953498 · Received July 23, 2014

    Report

    Report Number
    1063481-2014-00034
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 15, 2014
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    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

    A PATIENT RETURNED TO THE OPERATING ROOM 1.5 YEARS AFTER INITIAL OPERATION DUE TO USING BIOGLUE IN RARE INSTANCES AS A PRIMARY CLOSURE. BIOGLUE WAS APPLIED INITIALLY AS A PART OF AN AORTIC DISSECTION ON THE AORTA WITHOUT SUTURES. THE EXACT PLACEMENT OR CIRCUMSTANCES OF THE BIOGLUE PLACEMENT ARE UNKNOWN. A REOPERATION OCCURRED RECENTLY, THE SURGEON INSINUATED WITHIN THE LAST MONTH, BUT SPECIFICS WERE NOT GIVEN. THE RE-OPERATION OCCURRED BECAUSE THE BIOGLUE DEGRADED OVERTIME AND THE PATIENT STARTED BLEEDING. THE DATE OF THE INITIAL SURGERY OR THE RE-OPERATION IS UNKNOWN. THE SURGEON NOW UNDERSTANDS THAT BIOGLUE IS DEGRADEABLE. THE MANUFACTURING RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND THE PRODUCT MET ALL SPECIFICATIONS FOR RELEASE. THE INSTRUCTIONS FOR USE PROVIDES INSTRUCTION THAT BIOGLUE IS NOT TO BE USED AS A SUBSTITUTE FOR SUTURES AND/OR STAPLES. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS FOR TRENDS THAT MAY WARRANT ADDITIONAL ACTIONS IN THE FUTURE.

    Description of Event or Problem · 1

    SURGEON DESCRIBED PATIENTS COMING BACK TO THE OPERATING ROOM 1.5 YEARS AFTER INITIAL AORTIC DISSECTION SURGERY DUE TO USING BIOGLUE IN RARE INSTANCES AS A PRIMARY CLOSURE. BIOGLUE WAS APPLIED INITIALLY IN THE MIDST OF AN AORTIC DISSECTION ON THE AORTA WITHOUT SUTURES. THE EXACT PLACEMENT OR CIRCUMSTANCES ARE UNKNOWN. A RE-OPERATION OCCURED RECENTLY, INSINUATED WITHIN THE LAST MONTH, BUT SPECIFICS WERE NOT GIVEN. THE RE-OPERATIONS OCCURED BECAUSE THE BIOGLUE DEGRADED OVERTIME AND THE PATIENT STARTED BLEEDING. SURGEON NOW UNDERSTANDS THAT BIOGLUE IS DEGRADEABLE.

    Description of Event or Problem · 1

    SURGEON DESCRIBED PATIENTS COMING BACK TO THE OPERATING ROOM 1.5 YEARS AFTER INITIAL AORTIC DISSECTION SURGERY DUE TO USING BIOGLUE IN RARE INSTANCES AS A PRIMARY CLOSURE. BIOGLUE WAS APPLIED INITIALLY IN THE MIDST OF AN AORTIC DISSECTION ON THE AORTA WITHOUT SUTURES. THE EXACT PLACEMENT OR CIRCUMSTANCES ARE UNKNOWN. A RE-OPERATION OCCURED RECENTLY, INSINUATED WITHIN THE LAST MONTH, BUT SPECIFICS WERE NOT GIVEN. THE RE-OPERATIONS OCCURED BECAUSE THE BIOGLUE DEGRADED OVERTIME AND THE PATIENT STARTED BLEEDING. SURGEON NOW UNDERSTANDS THAT BIOGLUE IS DEGRADEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430284 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3510-5-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other