BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX?

    MDR report key: 22864692 · Received August 21, 2025

    Report

    Report Number
    2124215-2025-58697
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 29, 2025
    Report Date
    November 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783268
    PMA / PMN Number
    K121667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K160823.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K160823. DEVICE EVALUATED BY MANUFACTURER: NC QUANTUM APEX DEVICE WAS RETURNED FOR ANALYSIS. VISUAL, TACTILE AND MICROSCOPIC ANALYSIS WAS PERFORMED ON THE DEVICE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. THERE WAS A BREAK IN THE MIDSHAFT WITH THE CORE WIRE EXPOSED. THE MIDSHAFT WAS NOT RETURNED WITH THE DEVICE. THE POLYMER EXTRUSION APPEARS TO HAVE BEEN CUT WITH ONLY A PARTIAL SECTION OF THE EXTRUSION RETURNED (APPROXIMATELY 5.1CM OF IT WHEN MEASURED FROM THE DISTAL TIP). A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO TEARS OR PINHOLES IN THE BALLOON. BUMPER TIP SHOWED NO SIGNS OF DISTAL TIP DAMAGE. THE EVENT MAY HAVE BEEN INDICATING A POLYMER EXTRUSION BREAK RATHER THAN A TIP DETACHMENT, BUT THIS CANNOT BE CONFIRMED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY HEART DISEASE. A 12 X 3.00 MM NC QUANTUM APEX WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). NO DAMAGE WAS OBSERVED DURING UNPACKING OR PREPARATION, AND THE DEVICE ADVANCED SMOOTHLY OVER THE WIRE AND GUIDEWIRE. DURING THE PROCEDURE, THE BALLOON TIP DETACHED FROM THE CATHETER. IT WAS SUCCESSFULLY RETRIEVED BY USING A SECOND BALLOON TO EXTRACT IT FROM THE PATIENT. THE PROCEDURE SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT COMPLICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY HEART DISEASE. A 12 X 3.00 MM NC QUANTUM APEX WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). NO DAMAGE WAS OBSERVED DURING UNPACKING OR PREPARATION, AND THE DEVICE ADVANCED SMOOTHLY OVER THE WIRE AND GUIDEWIRE. DURING THE PROCEDURE, THE BALLOON TIP DETACHED FROM THE CATHETER. IT WAS SUCCESSFULLY RETRIEVED BY USING A SECOND BALLOON TO EXTRACT IT FROM THE PATIENT. THE PROCEDURE SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365729 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912412300 0036694096 08714729783268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention