BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC EMERGE

    MDR report key: 23513466 · Received November 10, 2025

    Report

    Report Number
    2124215-2025-81501
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    May 16, 2025
    Report Date
    November 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729847267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HEADACHE DURING PROCEDURE AND POST PROCEDURE PATIENT HAD NAUSEA, BUT DID NOT VOMIT. PATIENT WAS SEEN BY CONSULTANT, GIVEN 8MG ONDANSETRON, RESOLVED. EVENTS WERE RESOLVED WITHOUT SEQUELAE. DURING THE PROCEDURE, TWO 3.5X15MM NC EMERGE BALLOONS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2542592 NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 7313 0035763720 08714729847267

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention