BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX NON-COVERED TRACHEOBRONCHIAL STENT

    MDR report key: 1193274 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05083
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    JCT
    PMA / PMN Number
    K963241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: AS THE UNIT HAS NOT BEEN RETURNED A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND NO ANOMALIES OR DEVIATIONS DURING THE MANUFACTURE OF THIS BATCH OF DEVICES. THE MOST PROBABLE CAUSE OF THE REPORTED COMPLAINT IS DESIGN RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRACHEOBRONCHIAL STENTING TREATMENT PROCEDURE, THE STENT COULD NOT DEPLOY. A STENT HAD BEEN ADVANCED TO AN UNSPECIFIED STRICTURE. WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE SUTURE KNOTS WOULD NOT RELEASE. AS A RESULT, THE STENT COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED "RELATIVELY EASY" BY REMOVING THE GUIDE CATHETER. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PROCEDURE WAS EXTENDED FROM ONE HOUR. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX NON-COVERED TRACHEOBRONCHIAL STENT JCT BOSTON SCIENTIFIC M00568920 11740954

    Patients

    Seq Age Sex Outcome Treatment
    1