BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 3231886 · Received July 17, 2013

    Report

    Report Number
    1063481-2013-00027
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 17, 2013
    Report Date
    August 8, 2013
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL CONTACT. THE SURGEON COMPLETED TEN CHANNELS BEFORE THE HANDPIECE FAILURE, NOT TWO AS INITIALLY REPORTED. THE HOSPITAL CONTACT STATED THAT THE SURGEON MUST HAVE BEEN SATISFIED WITH TEN CHANNELS SINCE HE DID NOT OPEN A SECOND HANDPIECE FOR USE. THE CONTACT STATED THAT NO OTHER COMPLICATIONS WERE REPORTED AND THAT THERE WAS NO EVIDENCE OF THE PATIENT EXPERIENCING ANY TYPE OF HARM BECAUSE OF THE HANDPIECE FAILURE. THE PATIENT UNDERWENT CORONARY ARTERY BYPASS DURING THE SAME SURGICAL PROCEDURE BUT NO FURTHER DETAILS REGARDING THE SURGICAL PROCEDURE ARE AVAILABLE. THIS ADDITIONAL INFORMATION DOES NOT CHANGE THE CONCLUSIONS DRAWN IN THE INITIAL MEDWATCH REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, BIOGLUE WAS USED IN TREATING STANFORD TYPE B AORTIC DISSECTION IN DESCENDING AORTA REPLACEMENT ON (B)(6) 2013. THE PATIENT'S WHITE BLOOD CELL COUNT WAS ABOUT 15000, BUT ROSE ABOVE 20,000 AFTER SURGERY. THIS CONTINUED FOR ABOUT FIVE DAYS AND RETURNED BACK TO A NORMAL COUNT AFTER TWO WEEKS. TEN DAYS LATER, THE PATIENT¿S PROCALCITONIN LEVEL WAS MEASURED AT 6 UG/L. IT WAS USUALLY MEASURED AT ABOUT 0.5 UG/L. THE PATIENT HAS HAD A PREVIOUS PROCEDURE INVOLVING BIOGLUE IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332265 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3510-5-J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other