BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC EMERGE

    MDR report key: 23080498 · Received September 17, 2025

    Report

    Report Number
    2124215-2025-65540
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729847168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT POSTERIOR ATRIOVENTRICULAR BRANCH TO THE FIRST RIGHT POSTEROLATERAL BRANCH (R-PAV / 1ST-RPL) OF THE RIGHT CORONARY ARTERY. DURING THE SECOND BALLOON INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2552766 NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 7312 0033255419 08714729847168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown