BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION¿ SHORT THROW

    MDR report key: 3041368 · Received April 8, 2013

    Report

    Report Number
    3005099803-2013-02550
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A SENSATION SMALL OVAL SNARE WAS USED DURING A TRACHEAL POLYPECTOMY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH BURNT WHEN CAUTERY WAS APPLIED, CAUSING A MILD BURN IN THE PATIENT'S TRACHEA. THE PROCEDURE WAS ABORTED AND THE BURN WAS TREATED. THE PATIENT'S CONDITION FOLLOWING THE TREATMENT WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143094 SENSATION¿ SHORT THROW SMALL OVAL - FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562691

    Patients

    Seq Age Sex Outcome Treatment
    1 Other