BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 3773161 · Received April 25, 2014

    Report

    Report Number
    1063481-2014-00018
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    November 6, 2013
    Report Date
    March 31, 2014
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT SUBMITTED BY THE CRYOLIFE FIELD REPRESENTATIVE, "THE PRODUCT WAS APPLIED EPIDURAL. BIOGLUE GLUED WELL, CEREBROSPINAL FLUID DOES NOT FLOW OUT (IT IS NOT CEREBROSPINAL FISTULA). THE GLUE IS FLOWING OUT, AND IT CAUSED AN ASEPTIC INFLAMMATORY (HYPERSENSITIVITY) REACTION." ADDITIONAL INFORMATION RECEIVED BY FIELD ASSURANCE ON 04/17/2014 INDICATED THAT THE PROCEDURE PERFORMED WAS AS FOLLOWS: SUPRAORBITAL ENDOSCOPIC APPROACH TO OLFACTORY MENINGIOMA. EPIDURAL APPLICATION OF BIOGLUE BETWEEN DURA AND SUPRAORBITAL BONE FLAP (2.5 X 1.5 CM). ON 04/10/2014: "THEY OPENED THE PATIENT AND CLEANED. THE BIOGLUE WAS BLACK COLORED, GRANULATION AROUND. ON CT THERE ARE SIGNS OF OSTEITIS. THEY SENT SAMPLES FOR HISTOLOGY AND MICROBIOLOGICAL TESTS. THERE WAS NO COMPOST BUT IT WAS SOME GELATIN MUCUS (GRANULATION TISSUE?)." CLARIFYING INFORMATION INCLUDING MICROBIOLOGY AND HISTOLOGY RESULTS, OTHER PRODUCTS/DEVICES USED, AND AN EXPLANATION OF WHAT IS MEANT BY THE "GLUE IS FLOWING OUT" WAS REQUESTED FROM THE DISTRIBUTOR. THE DISTRIBUTOR CONFIRMED THAT THE HOSPITAL WAS UNWILLING TO PROVIDE ADDITIONAL INFORMATION. THE REPORT INDICATES THAT BIOGLUE WAS APPLIED BETWEEN THE DURA AND A SUPRAORBITAL BONE FLAP. HOWEVER, IT IS UNCLEAR IF BIOGLUE WAS USED IN CONJUNCTION WITH SUTURES OR SOME OTHER PRIMARY CLOSURE MECHANISM. FURTHERMORE, IT IS UNCLEAR WHAT IS MEANT BY "THE GLUE IS FLOWING OUT" SINCE BIOGLUE POLYMERIZES WITHIN TWO MINUTES OF APPLICATION AND WILL REMAIN IN THE SOLID STATE UNTIL COMPLETELY RESORBED. AN ASEPTIC INFLAMMATORY (HYPERSENSITIVITY) REACTION WAS NOTED, HOWEVER, NO ADDITIONAL DETAILS REGARDING THE NATURE OF THIS REACTION ARE AVAILABLE. THIS MAY REPRESENT A POSSIBLE ALLERGIC REACTION. ALLERGIC REACTIONS ARE POSSIBLE IN PATIENTS PREVIOUSLY SENSITIZED TO BOVINE PROTEINS. ADEQUATE PRECAUTIONS AND WARNINGS CONCERNING HYPERSENSITIVITY REACTIONS ARE PROVIDED IN THE BIOGLUE INSTRUCTIONS FOR USE. THE NATURE AND RELATIONSHIP TO BIOGLUE OF THE "OSTEITIS" NOTED ON CT SCAN IS ALSO UNKNOWN. THE HISTOLOGY RESULTS FROM EXAMINATION OF THE REMOVED MATERIAL SHOWED GRANULATION TISSUE WITH NO NECROSIS ("COMPOST" WAS UNDERSTOOD TO MEAN NECROSIS), WHICH IS CONSISTENT WITH A NORMAL HEALING SURGICAL SITE. ALL MANUFACTURING RECORDS ASSOCIATED WITH THE LOT WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS. NO DEFINITIVE CONCLUSIONS CAN BE MADE WITH THE AVAILABLE INFORMATION TO DETERMINE IF BIOGLUE CONTRIBUTED TO THE REPORTED EVENT. WHILE IT IS POSSIBLE THAT THIS EVENT REPRESENTS AN ALLERGIC/HYPERSENSITIVITY REACTION, ADEQUATE PRECAUTIONS AND WARNINGS ARE PROVIDED IN THE BIOGLUE IFU. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT RECEIVED BY THE DISTRIBUTOR, "THE PRODUCT WAS APPLIED EPIDURAL. BIOGLUE GLUED WELL, CEREBROSPINAL FLUID DOES NOT FLOW OUT (IT IS NOT CEREBROSPINAL FISTULA). THE GLUE IS FLOWING OUT, AND IT CAUSED AN ASEPTIC INFLAMMATORY (HYPERSENSITIVITY) REACTION". ON (B)(6) 2014, THE PATIENT WAS OPENED AND CLEANED. THE BIOGLUE WAS BLACK COLORED, GRANULATION AROUND. ON CT, THERE ARE SIGNS OF OSTEITIS. THEY SENT SAMPLES FOR HISTOLOGY AND MICROBIOLOGICAL TESTS. THERE WAS NO COMPOST BUT IT WAS SOME GELATIN MUCUS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT RECEIVED BY THE DISTRIBUTOR, "THE PRODUCT WAS APPLIED EPIDURAL. BIOGLUE GLUED WELL, CEREBROSPINAL FLUID DOES NOT FLOW OUT (IT IS NOT CEREBROSPINAL FISTULA). THE GLUE IS FLOWING OUT, AND IT CAUSED AN ASEPTIC INFLAMMATORY (HYPERSENSITIVITY) REACTION". ON (B)(6) 2014 THE PATIENT WAS OPENED AND CLEANED. THE BIOGLUE WAS BLACK COLORED, GRANULATION AROUND. ON CT THERE ARE SIGNS OF OSTEITIS. THEY SENT SAMPLES FOR HISTOLOGY AND MICROBIOLOGICAL TESTS. THERE WAS NO COMPOST BUT IT WAS SOME GELATIN MUCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251491 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. 13MHV114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other