BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION? SHORT THROW

    MDR report key: 4265979 · Received November 20, 2014

    Report

    Report Number
    3005099803-2014-03619
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Report Date
    October 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE 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. (B)(4) FOR THE REPORTED EVENT OF CURRENT FAILURE. THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR THE DEVICE IS RETURNED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE WAS USED. ACCORDING TO THE COMPLAINANT, THE SNARE FAILED TO DELIVER CURRENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE WAS USED. ACCORDING TO THE COMPLAINANT, THE SNARE FAILED TO DELIVER CURRENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752500 SENSATION? SHORT THROW SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562673

    Patients

    Seq Age Sex Outcome Treatment
    1