BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 3150798 · Received June 6, 2013

    Report

    Report Number
    2134265-2013-04402
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A COIL EMBOLIZATION TREATMENT PROCEDURE COIL DISLOCATION OCCURRED. THE DISLOCATED COIL WAS "SALVAGED." NO FURTHER PATIENT COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250330 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK UNK297

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention