BEUDAMED
    FDA Adverse Event Death Summary report: N

    HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML

    MDR report key: 5787999 · Received July 12, 2016

    Report

    Report Number
    2916714-2016-00540
    Event Type
    Death
    Date Received
    July 12, 2016
    Report Date
    February 3, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    NARRATIVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: ISRAEL. APPROXIMATELY THREE WEEKS AGO A COMPLAINT WAS RECEIVED FROM A GASTROENTEROLOGICAL CENTER, REGARDING THE USE OF HISTOACRYL AS A TREATMENT TO VARICES. SHORTLY AFTER PROCEDURE, PATIENT SUFFERED FROM BRADYCARDIA FOLLOWED BY ASYSTOLE. IT WAS REPORTED THAT THE CLINICAL SIGNS SUPPORT SUSPECTED MASSIVE PE (PULMONARY EMBOLISM) AS THE CAUSE OF DEATH.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 3 UNITS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. (B)(4) UNITS OF THIS CODE BATCH WERE MANUFACTURED AND DISTRIBUTED TO CUSTOMERS IN (B)(4) COUNTRIES. THERE ARE NO UNITS IN STOCK. VISUAL AND FUNCTIONAL EXAMINATIONS OF THE RECEIVED SAMPLES REVEALED NO UNEXPECTED OBSERVATIONS AND SAMPLES MET ALL REQUIREMENTS. ADHESIVE FORCE RESULTS OF TESTED SAMPLES ARE WELL ABOVE REQUIREMENT. THE RESULTS ARE 684,9 N AND THE REQUIREMENT IS > 20 N. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. THE COMPLICATION OF EMBOLISM WITH FATAL RESULTS HAS BEEN DESCRIBED IN THE LITERATURE, E.G. MARION-AIDIBERT ET AL., GASTROENTEROL. CLINI. BIOL. 2008; 32:926-930; VAN BEEK AP & VAN ERPECUM KJ, ENDOSCOPY 2005; 37:687; JAVED A & SALAMAT A, J AYUB MED. COLL ABOTTABAD 2008; 20:143-145. IT IS REFERENCE IN THE INSTRUCTIONS FOR USE AS A RISK IN THE WARNING NOTE: "FURTHERMORE, IT CANNOT BE ENTIRELY RULED OUT THAT HISTOACRYL EMBOLISADES MAY, FOR EXAMPLE, GET WASHED INTO THE LUNGS, POTENTIALLY RESULTING IN PULMONARY EMBOLISM."· WITH ALL RECEIVED INFORMATION AND ACCORDING TO THE RESULTS OF THE SAMPLES TESTED AND MANUFACTURING RECORD REVIEW, THE PRODUCT COMPLIES WITH OUR SPECIFICATIONS. THEREFORE WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFILL THE OEM SPECIFICATIONS, NOTE OF THIS INCIDENT IS TAKEN IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438955 HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050052 215402N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death