BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX

    MDR report key: 23554969 · Received November 14, 2025

    Report

    Report Number
    2124215-2025-82109
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    November 13, 2024
    Report Date
    November 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS 1: (B)(6). E1: INITIAL REPORTER PHONE: (B)(6). G4: PREMARKET / 510(K) #: K121667, K160823. DEVICE EVALUATED BY MFR. : NC QUANTUM APEX MR 8MM X 3.00MM WAS RETURNED FOR ANALYSIS. VISUAL AND TACTILE INSPECTION REVEALED NO ISSUES WERE IDENTIFIED IN THE HYPOTUBE SHAFT PROFILE AND SHAFT POLYMER EXTRUSION PROFILE. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A LONGITUDINAL TEAR IN THE BALLOON (8MM IN LENGTH). NO ISSUES OR DAMAGES WERE IDENTIFIED. A MICROSCOPIC EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO DAMAGE. A DETAILED MICROSCOPIC EXAMINATION OF THE SHAFT POLYMER EXTRUSION IDENTIFIED KINKS IN THE INNER LUMEN UNDER THE LOCATION OF THE BALLOON TEAR.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-OCT-2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. AN 8MM X 3.00MM NC QUANTUM APEX BALLOON WAS SELECTED FOR USE. HOWEVER, IT DID NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832968 NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912408300 0032940587 08714729783152

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male