BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC EMERGE

    MDR report key: 23268211 · Received October 10, 2025

    Report

    Report Number
    2124215-2025-72072
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6) MEDICAL CENTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 5.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, AT 12 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124346 NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 7312 0033557805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown