BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 3150751 · Received June 6, 2013

    Report

    Report Number
    2134265-2013-04397
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MENSEL, BIRGER, MD. ET AL (2012). "SELECTIVE MICROCOIL EMBOLIZATION OF ARTERIAL GASTROINTESTINAL BLEEDING IN THE ACUTE SITUATION: OUTCOME, COMPLICATIONS, AND ACTORS AFFECTING TREATMENT SUCCESS." EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY; 24 (2012): 155¿163. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT POST A COIL EMBOLIZATION PROCEDURE FOR GASTROINTESTINAL BLEEDING INTESTINAL ISCHEMIA AND HEMATOMA OCCURRED. THE HEMATOMA OCCURRED POST INTERVENTION IN THE INGUINAL REGION, WHICH WAS TREATED SURGICALLY. NO FURTHER PATIENT COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250992 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK UNK297

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention