BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX

    MDR report key: 22513207 · Received July 15, 2025

    Report

    Report Number
    2124215-2025-47379
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    February 18, 2025
    Report Date
    July 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K121667, K160823. DEVICE EVALUATED BY MFR.: NC QUANTUM APEX MR 15MM X 3.00MM STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION REVEALED NO ISSUES OR DAMAGES NOTED IN THE HYPOTUBE. A VISUAL EXAMINATION OF THE BALLOON IDENTIFIED A COMPLETE CIRCUMFERENTIAL TEAR WITH THE DISTAL SECTION NOT RETURNED. A MICROSCOPIC EXAMINATION FOUND A COMPLETE CIRCUMFERENTIAL TEAR WAS NOTED IN THE MID-SECTION OF THE BALLOON, 22.6CM FROM THE PORT EXCHANGE WITH THE DISTAL SECTION WAS NOT RETURNED. NO KINKS OR DAMAGES NOTED IN THE SHAFT POLYMER EXTRUSION. BUMPER TIP SHOWED NO SIGNS OF DISTAL TIP DAMAGE. A MICROSCOPIC EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO DAMAGE.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10-JUL-2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535727 NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912415300 0033534898 08714729783374

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male