BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE - UNKNOWN CONFIGURATION

    MDR report key: 6177198 · Received December 15, 2016

    Report

    Report Number
    1063481-2016-00070
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    October 8, 2015
    Report Date
    February 20, 2017
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION COULD BE OBTAINED. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS LOT NUMBERS ARE UNKNOWN. THE SURGEON REPORTED BIOGLUE APPLIED INTRAOPERATIVELY SEEPED THRU THE SUTURE LINE AND CAUSED THE "LEAFLET TO STICK," THE IFU PROVIDES THE FOLLOWING INFORMATION: ¿DO NOT EXPOSE VALVE LEAFLETS OR INTRACARDIAC STRUCTURES TO BIOGLUE. APPLY AN EVEN COATING OF BIOGLUE TO THE TARGET AREA. IN GENERAL, USE AN APPROXIMATELY 1.0-3.0MM THICK COATING FOR VESSELS THAT ARE GREATER THAN 2.5MM IN DIAMETER OR AN APPROXIMATELY 0.5-1.0MM THICK COATING FOR VESSELS THAT ARE LESS THAN 2.5CM IN DIAMETER. BIOGLUE SHOULD BE USED ONLY WHEN COMPLETE VISUALIZATION OF THE TARGET APPLICATION LOCATION IS POSSIBLE, WHEN IT IS PROPERLY PRIMED TO ACHIEVE OPTIMAL VISCOSITY, AND A MINIMAL AMOUNT IS USED." THE IFU LISTS FAILURE OF BIOGLUE TO ADHERE TO TISSUE AS POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH THE USE OF BIOGLUE. ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN.

    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 THE SURGEON MENTIONED THAT DURING A PROCEDURE BIOGLUE SEEPED THROUGH THE SUTURES AND CAUSED THE IMPLANTED VALVE LEAFLET TO STICK.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT THE SURGEON MENTIONED THAT DURING A PROCEDURE BIOGLUE SEEPED THROUGH THE SUTURES AND CAUSED THE IMPLANTED VALVE LEAFLET TO STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825988 BIOGLUE - UNKNOWN CONFIGURATION GLUE, SURGICAL, ARTERIES MUQ CRYOLIFE, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other