BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION? SHORT THROW

    MDR report key: 3922626 · Received July 9, 2014

    Report

    Report Number
    3005099803-2014-02468
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED EVENT: WIRE FAILED TO DELIVER CURRENT. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02468 FOR THE SENSATION SNARE, AND MANUFACTURER REPORT # 3005099803-2014-02509 FOR THE ACTIVE CORD. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE AND AN ACTIVE CORD DEVICE WERE USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WOULD NOT CAUTERIZE A PEDUNCULATED POLYP. IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE TO THE DEVICE PRIOR TO USE. THE USERS WERE UNABLE TO CONFIRM IF THE ISSUE OCCURRED DUE TO THE SNARE, OR DUE TO THE ACTIVE CORD. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401967 SENSATION? SHORT THROW SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562670

    Patients

    Seq Age Sex Outcome Treatment
    1