BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 24436953 · Received February 24, 2026

    Report

    Report Number
    3014162263-2026-00008
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    September 5, 2025
    Report Date
    February 24, 2026
    Manufacturer
    BALT USA
    Product Code
    HCG
    PMA / PMN Number
    K200030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BALT USA REFERENCE: (B)(4). 26JAN2026: ADDITIONAL INFORMATION WAS RECEIVED FROM THE ISSUER REGARDING THIS INCIDENT. THEREFORE, AN UPDATED REPORTABILITY EVALUATION WAS DOCUMENTED WHICH DETERMINED THIS INCIDENT SHOULD BE UPGRADED TO REPORTABLE BASED ON THE ADDITIONAL INFORMATION RECEIVED. AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED AS DEVICE WAS UNAVAILABLE TO BE RETURN. BASED ON THE PROVIDED INFORMATION, ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. LACK OF 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. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OF THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE PATIENT HAD A CAVERNOUS ICA ANUE MEASURING 14MMX10.5 MM WITH A NECK OF 3.0MM, PROCEDURE PLANNED WAS BALLOON ASSISTED COILING. THE SUPPORT SYSTEM WAS NEURONMAX, NAVIAN 6F, VASCO 10 MP, TRAXCESS 14 AND COPERNIC 5X20 BALLOON. THE VASCO 10 MP WAS CONNECTED WITH A HEP SALINE FLUSH AND PLACED INSIDE THE ANUE AND COPERNIC 5/20 ACROSS THE NECK. OPTIMA COIL 12X40 WAS TAKEN AND PRECHECKED WITH A NEW EXCEL DETACHER AND THE BALLOON WAS INFLATED AND OPTIMA COIL WAS ATTEMPTED TO BE PLACED INSIDE THE ANOTHER PHYSICIAN WAS NOT FEELING ANY FORWARD OR BACKWARD MOVEMENT OF THE COIL. THE BALLOON WAS DEFLATED AND THE ENTIRE COIL ALONG WITH THE MICRO WAS REMOVED. THE COIL PUSHER CAME OUT WITHOUT ANY MOVEMENT AND THE COIL WAS FLUSHED OUT FROM THE MICRO. ANOTHER OPTIMA 11X37 WAS TAKEN AND 8 MORE COILS WERE PLACED WITH BALLOON INFLATION. SUBSEQUENTLY FEW COIL LOOPS WERE IN THE PARENT VESSEL. THE PHYS DEPLOYED A 3.25X25 SVB AND THE PROCEDURE WAS COMPLETED." UPDATE (B)(6) 2026: ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "THE SVB WAS NOT PART OF THE PLAN. POST PROCEDURE THERE WAS THROMBUS FORMATION IN THE NECK OBSTRUCTING FLOW INTO MCA BCZ OF COIL LOOP PROTRUSION INTO THE PARENT VESSEL." UPDATE(B)(6) 2026: ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. WOULD YOU BE ABLE TO CONFIRM IF THE 12X40 OPTIMA COIL WAS FLUSHED OUT IN THE BACK TABLE (OUTSIDE OF THE PATIENTS BODY)? YES. 2. THE COMPLAINT FORM STATED, "SUBSEQUENTLY FEW COIL LOOPS WERE IN THE PARENT VESSEL." WOULD YOU KNOW WHAT COILS WOULD BE INVOLVED IN THE PARENT VESSEL? NO IDEA. 3. THE COMPLAINT FORM STATES NO PATIENT INJURY, HOWEVER, THERE WAS A THROMBUS THAT OCCURRED. COULD YOU CONFIRM THE CURRENT PATIENT STATUS? ALIVE INTACT " INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488528 OPTIMA COIL SYSTEM OPTIMA HCG BALT USA OPTIMA COIL SYSTEM NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention