BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR SE MICROSPHERES

    MDR report key: 1982807 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00444
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    HCG
    PMA / PMN Number
    K071634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: 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 THAT DURING AN OVARIAN EMBOLIZATION PROCEDURE, A CONTOUR 500-700/2ML CONTOUR SE MICROSPHERES SYRINGE WAS SELECTED AND INJECTED INTO LEFT OVARIAN ARTERY. UPON ATTEMPTING TO EMBOLIZE THE RIGHT OVARIAN ARTERY IT "SEEMS LIKE THE ARTERY IS ALREADY EMBOLIZED." THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR SE MICROSPHERES DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - MAPLE GROVE M001761372

    Patients

    Seq Age Sex Outcome Treatment
    1