BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 9944318 · Received April 9, 2020

    Report

    Report Number
    3014162263-2020-00007
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 2, 2020
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    UDI-DI
    00818053025761
    PMA / PMN Number
    K200030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO WHOM IT MAY CONCERN: ON MARCH 13, 2020, BALT USA RECEIVED A COMPLAINT REGARDING THE USE OF A SINGLE OPTIMA COIL (1.5MM X 4CM COMPLEX SUPER SOFT). DETAILS REPORTED AS FOLLOWS: "DURING REMOVAL OF MICRO-CATHETER, MIGRATION OF THE LAST COIL COMPLEX-10 SUPER SOFT." THE RESULTS OF OUR INVESTIGATION, ARE SUMMARIZED AS FOLLOWS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED AS THE DEVICE WAS REPORTED UNAVAILABLE. FOLLOW UP WAS MADE AND IT WAS REPORTED THAT THE DEFICIENCY DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH OF THE PATIENT. IT IS POSSIBLE THAT A COMBINATION OF COIL PLACEMENT AND INTERACTION WITH OTHER DEVICES AT THE TREATMENT SITE LED TO MIGRATION OF THE OPTIMA COIL; HOWEVER, LACK OF DEVICE RETURN PREVENTED DEEPER EVALUATION OF THE REPORTED ISSUE. REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOTS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST LOT NUMBER 041719A HAS BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DURING REMOVAL OF MICRO-CATHETER, MIGRATION OF THE LAST COIL COMPLEX-10 SUPER SOFT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408308 OPTIMA COIL SYSTEM OPTIMA HCG BALT USA, LLC OPTI0154CSS10 041719A 00818053025761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention