BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1813460 · Received August 24, 2010

    Report

    Report Number
    1063481-2010-00026
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P01003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ANY ADDITIONAL INFORMATION WILL BE INCLUDED IN A 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. 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

    ACCORDING TO THE REPORT, TWO SYRINGES OF BIOGLUE WERE USED IN A SURGERY FOR A CARDIAC TAMPONADE (PERICARDITIS). IN THE EVENING FOLLOWING THE SURGERY, THE PATIENT'S PLATELET COUNT DROPPED TO 7,000 (VS. 260,000 THE DAY PRIOR TO SURGERY). ETIOLOGIC CAUSES WERE EXPLORED, DISSEMINATED INTRAVASCULAR COAGULATION AND HEPARIN-INDUCED THROMBOCYTOPENIA, HAVE BEEN EXCLUDED. PLATELET LEVELS WERE SLOW TO RISE SEVEN DAYS AFTER THE SURGERY THE PLATELET COUNT WAS AT 10,000, NINE DAYS AT 70,000, AND ELEVEN DAYS AT 150,000. THE HOSPITAL INQUIRED INTO THE POSSIBILITY THAT BIOGLUE COULD HAVE ELICITED AN AUTOIMMUNE RESPONSE THAT CAUSED THE PLATELET COUNT TO DROP. AS SUCH AN INVESTIGATION WAS PERFORMED. NO BIOGLUE LOT NUMBER WAS REPORTED WITH THE COMPLAINT. THEREFORE, A QUALITY REVIEW OF THE LOT COULD NOT BE PERFORMED. A MEDICAL REVIEW OF THE COMPLAINT DETAILS REVEALED IT IS NOT LIKELY THAT BIOGLUE CONTRIBUTED OR CAUSED THE DESCRIBED DROP IN PLATELET COUNT. PLATELETS CAN BE CONSUMED OR DAMAGED DURING CARDIAC BYPASS BUT IT IS UNKNOWN IF BYPASS WAS UTILIZED DURING THIS PROCEDURE. TO DATE, THERE HAVE BEEN NO PREVIOUS COMPLAINTS OR DEFICIENCIES SUGGESTING PLATELET CONSUMPTION. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, TWO SYRINGES OF BIOGLUE WERE USED IN A SURGERY FOR A CARDIAC TAMPONADE (PERICARDITIS). IN THE EVENING FOLLOWING THE SURGERY, THE PATIENT'S PLATELET COUNT DROPPED TO 7,000 (VS. 260,000 THE DAY PRIOR TO SURGERY). ETIOLOGIC CAUSES WERE EXPLORED, DISSEMINATED INTRAVASCULAR COAGULATION AND HEPARIN INDUCED THROMBOCYTOPENIA, HAVE BEEN EXCLUDED. PLATELET LEVELS WERE SLOW TO RISE SEVEN DAYS AFTER THE SURGERY, THE PLATELET COUNT WAS AT 10,000, NINE DAYS AT 70,000, AND ELEVEN DAYS AT 150,000. THE HOSPITAL INQUIRED INTO THE POSSIBILITY THAT BIOGLUE COULD HAVE ELICITED AN AUTOIMMUNE RESPONSE THAT CAUSED THE PLATELET COUNT TO DROP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention