BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3823142 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02767
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 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 YRS. OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE 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 BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT MAIN TRUNK ARTERY. A 15MM X 5.00MM QUANTUM APEX¿ BALLOON CATHETER WAS SELECTED TO TREAT THE LESION. UPON FIRST INFLATION THE BALLOON WAS INFLATED AT 12 ATMOSPHERES (ATMS) AND ON SECOND INFLATION THE BALLOON RUPTURED AT 12 ATMS. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303815 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415500 16161457

    Patients

    Seq Age Sex Outcome Treatment
    1