(b)(4).The returned dreamtome was analyzed, and a visual evaluation noted that the cutting wire was detached, bent and blackened.It was noted that the cut in the cutting wire was not smooth.Additionally, the working length was bent at 56cm from handle and twisted in several locations.A functional evaluation could not be performed due to the condition of the device.No other visual issues with the device were noted.The reported event of wire failure to bow was confirmed.Upon analysis of the returned device, the cutting wire was detached, bent and blackened, disabling the device's ability to bow.The failure found could have been generated if the cutting wire was not completely in contact with the tissue when applying electrocautery current or by an excess of voltage.Additionally, the working length was observed bent and twisted.The failure found could have been generated by the factors encountered during the procedure, during advancing into the scope or by the technique used.The investigation concluded that the most probable cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
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It was reported to boston scientific corporation that a dreamtome rx 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during preparation, the dreamtome failed to bow.The procedure was completed with different device.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.This event has been deemed reportable based on the investigation results: cutting wire detached.
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