BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR 150-250 5 VIALS BX/5

    MDR report key: 764022 · Received September 14, 2006

    Report

    Report Number
    6000078-2005-00288
    Event Type
    Injury
    Date Received
    September 14, 2006
    Date of Event
    September 20, 2005
    Report Date
    September 21, 2005
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    HCG
    PMA / PMN Number
    K914866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTOUR VIAL WAS RETURNED FOR ANALYSIS AND THE COMPLAINT DESCRIPTION COULD NOT BE CONFIRMED. THE MICROBIOLOGICAL DEPARTMENT WITHIN BOSTON SCIENTIFIC CORK CARRIED OUT LAL (ENDOTOXIN) TESTING ON THE VIAL OF CONTOUR RETURNED AS PART OF THIS COMPLAINT AND THE RESULTS WERE FOUND TO BE WITHIN THE ACCEPTABLE RANGE FOR THIS PRODUCT (SEE ATTACHED RESULTS). IT HAS ALSO BEEN IDENTIFIED THAT SEPTIC SHOCK AS REPORTED IN THE COMPLAINT DESCRIPTION IS USUALLY ASSOCIATED WITH BACTERIAL INFECTION AND NOT A PYROGEN RELATED ISSUE. ALSO FROM THE COMPLAINT DESCRIPTION, THE PHYSICIAN DID NOT ASSOCIATE THE CONTOUR WITH THE REACTION FROM THE PATIENT, HE WAS UNDER THE IMPRESSION THAT THESE ISSUE WAS MOST LIKELY NOT AN INFLAMMATORY OR ALLERGIC REACTION TO THAT MATERIAL. FROM THE ANSWERS TO ADDITIONAL QUESTIONS ABOUT THE TESTING CARRIED OUT BY THE HOSPITAL IT WAS ESTABLISHED THAT THEIR TESTS HAD SHOWN NO BACTERIAL GROWTH ON THE CONTOUR PRODUCT. NO OTHER COMPLAINT HAS BEEN RECEIVED FOR THIS PARTICULAR BATCH OF DEVICES. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AN NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ADDITIONAL INFORMATION: FURTHER INFORMATION REGARDING THE COMPLAINT WAS REQUESTED AND FROM THE RESPONSE IT WAS ESTABLISHED THAT THE HOSPITAL CARRIED THEIR OWN MICROBIOLOGICAL TESTING. A CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED AS NO ISSUES HAVE BEEN IDENTIFED WITH THIS COMPLAINT. BOSTON SCIENTIFIC MANUFACTURING PROCESS INCLUDE EXTENSIVE TESTING AND INSPECTIONS TO ENSURE EACH PRODUCT MEETS OR EXCEEDS ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THIS REPORTED DEFECT WILL BE MONITORED AND TRENDED THROUGH THE MONTHLY COMPLAINTS REVIEW BOARD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC HAS BECOME AWARE OF THE FOLLOWING EVENT AFTER CONDUCTING A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS: 30 MINUTES AFTER EMBOLISATION OF A VERTEBRAL BODY METASTASIS, THE PATIENT SUFFERED A SEPTIC SHOCK WITH SHAKING CHILLS, HIGH FEVER AND CIRCULATORY DISORDERS AND WAS IMMEDIATELY TRANSFERED TO THE INTENSIVE STATION. THE FIRST SUSPICION WAS A SEPTIC REACTION. DR. MENTIONED THAT THERE COULD BE A COHERENCE BETWEEN THIS CASE AND ANOTHER ONE IN JULY HE DIDN'T REPORT. IN BOTH CASES, THE PATIENTS WERE EMBOLISED WITH CONTOUR PVA 150-250 WITH THE SAME DIAGNOSIS AND SAME REACTIONS. THE DEPARTMENT TOOK OUT SAMPLE OF CONTOUR PVA AND GAVE IT TO THE HYGIENE INSTITUTE FOR MICROBIOLOGICAL INVESTIGATION. IN THE OPINION OF DR., THERE WAS NO COMPLICATION IN THE EMBOLISATION CASE BUT COULD BE AN INFLAMMATORY OR ALLERGIC REACTION TO THAT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR 150-250 5 VIALS BX/5 PUSHABLE/INJECTABLE EMBOLICS HCG NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION 760025 7429984

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other