BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX

    MDR report key: 2103529 · Received May 26, 2011

    Report

    Report Number
    3005099803-2011-01816
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K963241
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE PART OR LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED WITHIN THE TRACHEA OF A PATIENT IN (B)(6) 1999. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A TRACHEAL LESION AS A RESULT OF TRACHEAL MALACIA. IT IS UNKNOWN IF THE TRACHEAL MALACIA WAS CAUSED BY CANCER. THE EXACT SIZE OF THE LESION IS UNKNOWN. ON (B)(6), 2011, THE PATIENT WAS HAVING TROUBLE BREATHING, SO THE PHYSICIAN PERFORMED AN ENDOSCOPIC PROCEDURE WHERE IT WAS DISCOVERED THAT ONE STENT WIRE HAD UNRAVELED AND WAS PROTRUDING INTO THE PATIENT'S TRACHEAL TISSUE. THE STENT WIRE DID NOT CAUSE ANY TISSUE DAMAGE, IT JUST CAUSED AN INCREASE OF MUCOUS TO BUILD UP. THE STENT WAS NOT BLOCKED WITH ANY TISSUE; JUST A MUCOUS PLUG. ON (B)(6), 2011 THE PHYSICIAN SUCCESSFULLY CUT THE STENT WIRE USING ENDOSCOPIC SCISSORS, AND REMOVED IT WITHOUT DIFFICULTY. THE STENT IS STILL IMPLANTED, AND NO FURTHER INTERVENTION IS PLANNED. THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY UNK449

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention