BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX

    MDR report key: 25293223 · Received May 26, 2026

    Report

    Report Number
    2124215-2026-28285
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    February 8, 2025
    Report Date
    May 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783138
    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). G4: PMA/510(K) # FIELD ON 3500A FORM: K121667, K160823. INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: NC QUANTUM APEX MR 8MM X 2.50MM STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT IDENTIFIED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN NOTED THE SHAFT WAS RUPTURED. BALLOON MATERIAL WAS REVIEWED. MICROSCOPIC EXAMINATION OF THE BALLOON IDENTIFIED NO PINHOLES OR TEARS IN THE BALLOON MATERIAL. BUMPER TIP SHOWED THAT THE DISTAL BUMPER TIP WAS SLIGHTLY FLARED. A MICROSCOPIC EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO DAMAGE. MICROSCOPIC EXAMINATION OF THE OUTER AND INNER LUMEN NOTED THE SHAFT WAS RUPTURED AT 23MM FROM THE TIP FOR 7MM IN LENGTH. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A RISK REVIEW WAS PERFORMED, AND IT CONFIRMED THAT THE EVENT WAS DEFINED IN THE RISK DOCUMENTATION AND IS RECORDED ACCORDINGLY IN THE PRODUCT RECORD REVIEW TABLE. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE CONCLUSION CODE OF CAUSE NOT ESTABLISHED. THIS CODE WAS SELECTED AS THE MOST PROBABLE COMPLAINT CAUSE BASED ON THE INFORMATION AVAILABLE. IT WAS REPORTED THIS NC EMERGE MR, OUS 4.00MM X 8MM WAS SELECTED FOR TREATMENT. HOWEVER, IT FAILED TO CROSS THE SEVERELY CALCIFIED LESION. EXAMINATION OF THE OUTER AND INNER LUMEN NOTED THE SHAFT POLYMER EXTRUSION WAS RUPTURED AT 23MM FROM THE TIP FOR 7MM IN LENGTH. IN ADDITION, THE DISTAL BUMPER TIP WAS SLIGHTLY FLARED. IT IS LIKELY THAT AN INTERACTION OCCURRED WITH THE DEVICE AND THE SEVERELY CALCIFIED LESION WHICH LIKELY CONTRIBUTED TO THE UNREPORTED TIP DAMAGE. BASED ON THE COMPLAINT INFORMATION AVAILABLE AND CONSIDERING THE CONDITION OF THE RETURNED DEVICE A CLEAR CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-MAY-2026. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. AFTER 2.00MM AND 2.25 MM NC QUANTUM APEX BALLOON CATHETERS CROSSED THE LESION, A 8MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER FAILED TO CROSS. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501005 NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912408250 0033745403 08714729783138

    Patients

    Seq Age Sex Outcome Treatment
    1