BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAMIC Y STENT

    MDR report key: 1181220 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04947
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NYT
    PMA / PMN Number
    K013266
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISCARDED. A DEVICE EVALUATION CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A DYNAMIC (Y) STENT DEVICE WAS PLACED ON THE SAME DAY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS PLACED IN THE ESOPHAGUS INSTEAD OF THE TRACHEA, AS INTENDED. THE PHYSICIAN RETRIEVED THE DYNAMIC Y STENT WITH A BIOPSY FORCEPS DEVICE (MANUFACTURER UNKNOWN, HOWEVER, IT WAS CONFIRMED THAT THE DEVICE WAS NOT A BOSTON SCIENTIFIC CORPORATION PRODUCT). DURING THE STENT RETRIEVAL, THE PATIENT'S ESOPHAGUS WAS TORN (IT WAS NOT KNOWN WHETHER THIS WAS A PARTIAL TEAR OR A FULL PERFORATION). ACCORDING TO THE COMPLAINANT, THE PHYSICIAN STATED THAT "THE STENT DID NOT CAUSE THE REPORTED TRAUMA. THE TRAUMA WAS CAUSED BY THE RETRIEVING FORCEPS." THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAMIC Y STENT NYT BOSTON SCIENTIFIC CORPORATION M00570690 0000007121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other