BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 3030165 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01849
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED. 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 DURING A CORONARY ARTERY TREATMENT PROCEDURE A BALLOON BURST OCCURRED. ACCESS WAS ACHIEVED VIA A RADIAL ARTERY. THE LESION BEING TREATED WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. THE DEVICE WAS USED FOR PRE DILATATION. THE 3.0X12MM NC QUANTUM APEX MONORAIL BALLOON RUPTURED ON THE 1ST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133526 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412300 15178839

    Patients

    Seq Age Sex Outcome Treatment
    1