BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 3250647 · Received July 26, 2013

    Report

    Report Number
    1063481-2013-00029
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 4, 2013
    Report Date
    August 23, 2013
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    ACCORDING TO THE REPORT, BIOGLUE WAS USED IN A PROCEDURE IN (B)(6) 2012. SUBSEQUENTLY, THE SURGEON FOUND A "PUNCH HOLE" ON THE PATIENT'S AORTA. A "GREAT" AMOUNT OF BIOGLUE WAS USED AND THE SURGEON DID NOT PROTECT THE SURROUNDING TISSUE WITH GAUZE. ON (B)(6) 2013, A BENTALL PROCEDURE WAS PERFORMED FOR REOPERATION. SAMPLES WERE COLLECTED DURING THE REOPERATION AND SENT TO CRYOLIFE FOR FURTHER EVALUATION. IT IS UNCLEAR EXACTLY WHAT WAS MEANT BY "PUNCH HOLE." HOWEVER, IT APPEARS THERE WAS A SIGNIFICANT TIME LAPSE BETWEEN THE DISCOVERY OF THE ALLEGED "PUNCH HOLE" AND REOPERATION. AN EMERGENCY SURGERY TO REPAIR THE "PUNCH HOLE" WAS NOT NECESSARY, WHICH MAKES THE REPORTED OBSERVATION MORE DIFFICULT TO DISCERN. PATHOLOGICAL EXAMINATION OF THE SAMPLES SHOWED MULTIPLES FRAGMENTS OF HYPEREOSINOPHILIC AMORPHOUS MATERIAL CONSISTENT WITH BIOGLUE AND NOTHING UNUSUAL WAS FOUND. THE FACT THAT THE SURGEON USED A "GREAT" AMOUNT OF BIOGLUE COULD SUGGEST THAT THE TISSUE WAS VERY FRAGILE AND THAT THE SURGEON WAS ATTEMPTING TO REINFORCE THE TISSUE WITH BIOGLUE. IF THIS WERE THE CASE, IT IS POSSIBLE THAT THE CONDITION OF THE TISSUE WAS THE CAUSE OF THE REPORTED EVENT. HOWEVER, WITH THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSIONS CAN BE MADE. NEVERTHELESS, THERE IS NOTHING TO SUGGEST THAT BIOGLUE CONTRIBUTED IN THE DEVELOPMENT OF THE ALLEGED "PUNCH HOLE."

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, BIOGLUE WAS USED IN A PROCEDURE. SUBSEQUENTLY, THE SURGEON FOUND A "PUNCH HOLE" ON THE PATIENT'S AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351593 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3510-5-J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other