(b)(4).Investigation results visual evaluation of the returned rx cytology brush found that the pull wire was broken at the distal end of the handle cannula.Functional analysis was not performed due to the condition of the returned device.Based on the evaluation of the returned device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and no deviations were found.
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This report pertains to the first of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-03392 and 3005099803-2017-03393 for the other associated device information.It was reported to boston scientific corporation that three rx cytology brushes were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the wire inside the catheters broke and the brushes were difficult to extend and retract.The procedure was completed with a 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 stable.
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