BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 5042101 · Received August 31, 2015

    Report

    Report Number
    1063481-2015-00212
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    August 1, 2012
    Report Date
    August 5, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, A SURGEON IN (B)(6) MENTIONED THAT HE HAD YEARS AGO PROBLEMS TO REOPERATE A PATIENT DUE TO A GLUE THAT HAS HARDENED AND THAT THIS PATIENT HAD TO UNDERGO HEART TRANSPLANT. THIS GLUE WAS BIOGLUE. THE SURGEON WAS CONTACTED FOR ADDITIONAL INFORMATION REGARDING THE LOT NUMBER OF BIOGLUE USED, DATE OF INITIAL OPERATION AND DETAILS OF HOW/WHERE BIOGLUE WAS APPLIED, DATE THE "HARD BIOGLUE" WAS DISCOVERED AND METHOD BY WHICH IT WAS DISCOVERED, OPERATIVE NOTES, IMAGING THAT SHOWS THE HARDENED BIOGLUE, AND PATIENT'S CURRENT STATUS. THE SURGEON REPLIED "I CANNOT REMEMBER THE PATIENTS' NAMES WHO CAUSED ME TROUBLE. THAT WAS A COUPLE OF YEARS AGO AND NOT SPECIFICALLY NOTED." NO INFORMATION WAS PROVIDED. A REVIEW OF MANUFACTURING RECORDS WAS NOT PERFORMED AS A LOT NUMBER FOR THE BIOGLUE IS UNKNOWN. THE DATE OF IMPLANT IS UNKNOWN; THEREFORE, SHIPPING RECORDS COULD NOT BE QUERIED FOR POSSIBLE LOT NUMBERS SHIPPED TO THE HOSPITAL. A REVIEW WAS PERFORMED OF THE AVAILABLE INFORMATION. AN OPERATION WAS PERFORMED USING BIOGLUE BY THE FORMER CHIEF OF SURGERY. THE REOPERATION WAS PERFORMED BY A DIFFERENT SURGEON WHO INDICATED THAT THE PLANNED PROCEDURE COULD NOT BE PERFORMED DUE TO THE HARDNESS OF BIOGLUE PRESENT. THE AMOUNT OF BIOGLUE UTILIZED IN THE INITIAL PROCEDURE IS UNKNOWN. BIOGLUE WILL REMAIN FLEXIBLE WHEN APPLIED IN THIN, EVEN LAYERS. IT IS POSSIBLE THAT AN INAPPROPRIATE AMOUNT OF BIOGLUE WAS APPLIED AND/OR BIOGLUE WAS NOT APPLIED IN THIN, EVEN LAYERS. THE ROOT CAUSE IS UNKNOWN. THE AVAILABLE INFORMATION OR DATA IS EXTREMELY LIMITED MAKING IT DIFFICULT TO DRAW ANY DEFINITIVE CONCLUSIONS. THE SURGEON WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS REGARDING THE EVENT. THE IFU STATES, "FOR VESSEL REPAIR APPLY AN EVEN ADHESIVE COATING 1.2 - 3.0 MM THICK FOR ANASTOMOSIS OF VESSELS/GRAFTS GREATER THAN 2.5 CM IN DIAMETER; APPLY AN EVEN ADHESIVE COATING 0.5 - 1.0 MM FOR VESSELS/GRAFTS LESS THAN 2.5 CM IN DIAMETER. FOR PARENCHYMAL REPAIR APPLY AN EVEN ADHESIVE COATING 1.5 - 3.0 MM THICK."

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A SURGEON IN (B)(6) MENTIONED THAT HE HAD YEARS AGO PROBLEMS TO REOPERATE A PATIENT DUE TO A GLUE THAT HAS HARDENED AND THAT THIS PATIENT HAD TO UNDERGO HEART TRANSPLANT. THIS GLUE WAS BIOGLUE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A SURGEON IN (B)(6) MENTIONED THAT HE HAD YEARS AGO PROBLEMS TO REOPERATE A PATIENT DUE TO A GLUE THAT HAS HARDENED AND THAT THIS PATIENT HAD TO UNDERGO HEART TRANSPLANT. THIS GLUE WAS BIOGLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574461 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other