BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3981342 · Received August 5, 2014

    Report

    Report Number
    2134265-2014-04578
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NON TORTUOUS PROXIMAL END OF THE LEFT CIRCUMFLEX ARTERY. A 15MM X 3.50MM NC QUANTUM APEX¿ BALLOON CATHETER WAS SELECTED AND ADVANCED TO DILATE THE LESION. THE BALLOON WAS INFLATED ONCE; HOWEVER, THE PRESSURE STOPPED INCREASING AT ABOUT 16-17 ATMOSPHERES. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457823 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415350 17005728

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: LAUNCHER7F| BALLOON CATHETER: CANPASS