BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3870390 · Received June 12, 2014

    Report

    Report Number
    3005099803-2014-02265
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED 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 ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ROUGHLY 6 MONTHS PRIOR TO (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. THERE WERE NO ISSUES NOTED WITH THE DEVICE PRIOR TO STENT PLACEMENT. IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT COUGHED UP THE STENT COVER. THE PHYSICIAN THEN REMOVED THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348187 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513750 15322704

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention