BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX

    MDR report key: 23822112 · Received December 16, 2025

    Report

    Report Number
    2124215-2025-91237
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729842910
    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 BALLOON RUPTURE OCCURRED. A 2.5MMX30MMX143CM COYOTE NC BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT THE INITIAL INFLATION PRESSURE OF 10 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING A DIFFERENT HIGH PRESSURE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661478 NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 24709 0033477745 08714729842910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown