BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3935694 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04228
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION, HOWEVER DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412863 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918908200

    Patients

    Seq Age Sex Outcome Treatment
    1