BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 10015325 · Received April 30, 2020

    Report

    Report Number
    3014162263-2020-00011
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    September 13, 2019
    Report Date
    April 29, 2020
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    PMA / PMN Number
    K200030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    TO WHOM IT MAY CONCERN: ON (B)(6) 2020, BALT USA RECEIVED A COMPLAINT REGARDING THE USE OF A SINGLE OPTIMA COIL. DETAILS REPORTED AS FOLLOWS: "THROMBUS FORMATION DURING COILING." THE RESULTS OF OUR INVESTIGATION, ARE SUMMARIZED AS FOLLOWS: -INCIDENT PART OF A CLINICAL STUDY. INITIAL NOTIFICATION IN (B)(6) 2019 WAS REPORTED AS A PROCEDURAL COMPLICATION NOT RELATED TO THE DEVICE. UPON FOLLOW UP MADE IN (B)(6) 2020 THE CUSTOMER HAD REPORTED A THROMBUS FORMATION. -AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED DEVICE WAS REPORTED UNAVAILABLE. ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. LACK OF ADDITIONAL INFORMATION AND DEVICE RETURN PREVENTED DEEPER EVALUATION OF THE REPORTED ISSUE. THE LOT NUMBER WAS NOT PROVIDED THEREFORE; A REVIEW OF THE LOT HISTORY RECORDS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THROMBUS FORMATION DURING COILING. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479808 OPTIMA COIL SYSTEM OPTIMA HCG BALT USA, LLC NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention