BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX

    MDR report key: 21602018 · Received March 13, 2025

    Report

    Report Number
    2124215-2025-15849
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783176
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE PATIENT, DIAGNOSED WITH CORONARY ARTERY DISEASE (CAD), WAS ADMITTED FOR CARDIAC CATHETERIZATION TO UNDERGO PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). A 90% STENOSED TARGET LESION WAS IDENTIFIED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. THE PROCEDURE BEGAN WITH CANNULATION OF THE ARTERY USING A 3.5 MACH FR CATHETER. THE SAMURAI CORONARY GUIDE WAS THEN ADVANCED, AND AN 8MM X 3.5MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR THE INTERVENTION. HOWEVER, WHILE ATTEMPTING TO ADVANCE THE BALLOON THROUGH THE GUIDE CATHETER, THE PROXIMAL SEGMENT OF THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357367 NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912408350 0034334177 08714729783176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown