BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE 2L

    MDR report key: 24715295 · Received March 30, 2026

    Report

    Report Number
    3014162263-2026-00019
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 27, 2026
    Manufacturer
    BALT EXTRUSION
    Product Code
    MJN
    UDI-DI
    03700481332481
    PMA / PMN Number
    K183045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BALT USA REFERENCE#: (B)(4). CONCLUSION OF INVESTIGATION PENDING ANALYSIS FROM LEGAL MANUFACTURER, BALT EXTRUSION. THIS REPORTED COMPLAINT CONCERNS A BALT EXTRUSION DEVICE. AS LEGAL MANUFACTURER, BALT EXTRUSION IS RESPONSIBLE FOR THE ALL-POST-MARKET ACTIVITIES INCLUDING THE INVESTIGATION, ROOT CAUSE, AND CUSTOMER FOLLOW-UP RELATED TO THIS COMPLAINT. BALT USA COMMERCIALIZES A SIMILAR DEVICE IN THE US MARKET, WHICH IS ALSO MANUFACTURED BY BALT EXTRUSION, AND HAS INITIATED THIS COMPLAINT FOR THE SOLE PURPOSES OF EVALUATION FOR POTENTIAL REPORTABILITY UNDER UNITED STATES MDR REQUIREMENTS. 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: "A 41-YEAR-OLD PATIENT WAS SCHEDULED TO UNDERGO BALLOON REMODELING OF A 7 MM PARAOPHTHALMIC ANEURYSM USING AN ECL2L. AFTER THE BALLOON WAS POSITIONED, THE MICROCATHETER WAS PLACED IN THE ANEURYSM. AN OPTIMAX WAS RELEASED INTO THE ANEURYSM AND THE BALLOON WAS INFLATED FOR CONTROL. THE ECL WAS THEN TO BE DEFLATED, WHICH UNFORTUNATELY WAS NOT POSSIBLE. AN ATTEMPT WAS EVEN MADE TO DEFLATE IT USING A 20 ML VACLOK SYRINGE. THE ECL HAD TO BE REMOVED FULLY INFLATED. THIS WAS VERY CRITICAL. THE USER IS EXTREMELY EXPERIENCED WITH THE ECL. THE ECL WAS PREPARED EXACTLY ACCORDING TO THE IFU AND TESTED BEFORE USE. THE PATIENT'S ANATOMY WAS DESCRIBED AS UNCOMPLICATED." 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
    775357 ECLIPSE 2L ECLIPSE MJN BALT EXTRUSION ECL2L6X20 00636314 03700481332481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention