(b)(4).Visual evaluation of the returned rx cytology brush found that the handle was slightly bent.The handle was disassembled and it was found that the pull wire was kinked at the hypotube joint.The pull wire was completely removed and further evaluation noted that the pull wire near to the bristled portion of the brush was slightly bent.Functional evaluation revealed that the brush failed to extend.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.A search of the complaint database revealed that no other complaints exist for the specified lot.
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It was reported to boston scientific corporation that an rx cytology brush was 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 brush bent and it was noted that the device failed to extend.The procedure was completed with another rx cytology brush.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.
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