BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERGE?

    MDR report key: 3163432 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-03845
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE 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 DURING A CORONARY TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. DURING THE PROCEDURE INSIDE THE PATIENT THE SHAFT OF A 1.50MM X 15MM EMERGE BALLOON CATHETER BROKE NEAR THE BALLOON AND DETACHED. A SNARE WAS USED TO REMOVE THE PORTION OF THE BROKEN DEVICE. THE EVENT WAS REPORTED TO HAVE CREATED CARDIAC TAMPONADE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT STATUS WAS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264700 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315150 0015778977

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention