BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 2200216 · Received August 11, 2011

    Report

    Report Number
    1063481-2011-00044
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    August 2, 2011
    Report Date
    October 4, 2011
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P01003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, A DAVID REIMPLANTATION PROCEDURE WAS PERFORMED ON A MARFAN SYNDROME PATIENT ON (B)(6), 2011. BIOGLUE WAS USED AT THE SUTURE LINES OF THE PROSTHETIC GRAFT ANASTOMOSIS SITES AT BOTH DISTAL AND PROXIMAL AS WELL AS AT CORONARY BUTTONS. BIOGLUE ACCIDENTALLY SPREAD AROUND TO SURROUNDING TISSUES (AORTA, PULMONARY ARTERY AND RCA) DUE TO EXCESSIVE APPLICATION. AS A RESULT BIOGLUE HAD COMPRESSED AND CAUSED THE CORONARY ARTERY TO KINK, CAUSING INTRAOPERATIVE RIGHT CORONARY INFARCTION. AN IMMEDIATE CABG PROCEDURE WAS PERFORMED DURING THE OPERATION. AT THE END OF THE PROCEDURE, THERE WAS A BLEEDING FROM THE UNDERSIDE OF THE AORTA. SINCE THE AORTA AND THE PULMONARY ARTERY HAD STUCK TOGETHER WITH BIOGLUE, IT WAS DIFFICULT TO POSITION THE AORTA FOR RECOVERY. THE SURGEON HAS COMMENTED THAT HE WILL BE MORE CAUTIOUS AT APPLICATION OF BIOGLUE AS THIS INCIDENT IS DUE TO MISUSE. POSTOPERATIVE COURSE OF THE PATIENT IS UNEVENTFUL. QUALITY REVIEWED THE DEVICE HISTORY RECORDS FOR LOT 11MJX006 AND CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL PHYSICAL, FUNCTIONAL, MICROBIAL, AND CHEMICAL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THIS EVENT LIKELY REPRESENTS A CASE OF EXCESSIVE APPLICATION AND APPLICATION OF BIOGLUE TO UNINTENDED SITES. THE BIOGLUE INSTRUCTIONS FOR USE PROVIDES SUFFICIENT PRECAUTIONS AGAINST APPLYING TO UNINTENDED SITES AND EXCESSIVE APPLICATION. NO FURTHER ACTION IS WARRANTED AT THIS TIME. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FUTHERMORE, THIS REPORT RELECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A REOPERATION PROCEDURE WAS PERFORMED ON A MARFAN SYNDROME PATIENT ON (B)(6) 2011. BIOGLUE WAS USED AT THE SUTURE LINES OF THE PROSTHETIC GRAFT ANASTOMOSIS SITES AT BOTH DISTAL AND PROXIMAL AS WELL AS AT CORONARY BUTTONS. BIOGLUE ACCIDENTALLY SPREAD AROUND TO SURROUNDING TISSUES (AORTA, PULMONARY ARTERY AND RCA) DUE TO EXCESSIVE APPLICATION. AS A RESULT BIOGLUE HAD COMPRESSED AND CAUSED THE CORONARY ARTERY TO KINK, CAUSING INTRAOPERATIVE RIGHT CORONARY INFARCTION. IMMEDIATE CABG PROCEDURE WAS CARRIED OUT. AT THE END OF THE PROCEDURE, THERE WAS A BLEEDING FROM THE UNDERSIDE OF THE AORTA. SINCE THE AORTA AND THE PULMONARY ARTERY HAD STUCK TOGETHER WITH BIOGLUE, IT WAS DIFFICULT TO POSITION THE AORTA FOR RECOVERY. THE SURGEON HAS COMMENTED THAT HE WILL BE MORE CAUTIOUS AT APPLICATION OF BIOGLUE AS THIS INCIDENT IS DUE TO MISUSE. POSTOPERATIVE COURSE OF THE PATIENT IS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL GLUE MUQ CRYOLIFE, INC. BG3510-5-J 11MJX006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R