BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER?

    MDR report key: 3808407 · Received May 13, 2014

    Report

    Report Number
    2134265-2014-02534
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQY
    PMA / PMN Number
    K021721
    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 BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON CALCIFIED ARCH OF THE AORTA. A EQL/40/7/2/100 EQUALIZER BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. IT WAS SUSPECTED THAT THE BALLOON RUPTURED. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNKNOWN. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287285 EQUALIZER? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK M001171120 16022801

    Patients

    Seq Age Sex Outcome Treatment
    1