BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE

    MDR report key: 21384991 · Received February 14, 2025

    Report

    Report Number
    2124215-2025-08511
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 31, 2025
    Report Date
    February 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K): K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION THE BALLOON RUPTURED, AND BLACK FOREIGN MATTER WAS SEEN IN THE INFLATION DEVICE WHEN THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414836 EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918915250 0033880835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown