BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 23707016 · Received December 3, 2025

    Report

    Report Number
    2124215-2025-86476
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 2, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783268
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. FOLLOWING STENT DEPLOYMENT, A 12MM X 3.00MM NC QUANTUM APEX? BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. DURING THE PROCEDURE, THE BALLOON SHAFT BROKE, AND THE RETRIEVAL OF THE DEVICE WAS DIFFICULT. THE DEVICE WAS EVENTUALLY RETRIEVED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2845526 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912412300 0035931887 08714729783268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown