BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 23758669 · Received December 9, 2025

    Report

    Report Number
    2124215-2025-89843
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    February 24, 2025
    Report Date
    December 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783145
    PMA / PMN Number
    K121667
    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): K160823. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. DEVICE EVALUATED BY MFR: AN NC QUANTUM APEX MR 8MM X 2.75MM, CATHETER WAS RETURNED FOR ANALYSIS. VISUAL AND TACTILE INSPECTION REVEALED NO ISSUES IDENTIFIED ON THE HYPOTUBE AND SHAFT POLYMER EXTRUSION. A MICROSCOPIC EXAMINATION OF THE BALLOON IDENTIFIED A 1CM LONGITUDINAL TEAR IN THE MID-SECTION OF THE BALLOON MATERIAL. DISTAL TIP SHOWED NO SIGNS OF DAMAGE. A MICROSCOPIC EXAMINATION OF THE DISTAL AND PROXIMAL MARKERBANDS IDENTIFIED NO DAMAGE. NO OTHER DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 24NOV2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AN 8MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. BUT THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON LONGITUDINAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797617 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912408270 0032818800 08714729783145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male