(b)(4).Investigation results: visual evaluation of the returned device found that residues were present which indicate use and handling.Further evaluation noted that the working length including the catheter and pull wire had been kinked in multiple locations throughout.The pull wire was found broken at the distal end and the bristled portion of the brush was not present and was not returned for evaluation.In addition, the pull wire presents drag marks that were probably caused by the customer at the time the pull wire was cut off.The guidewire channel was torn all the way until the distal tip and the ring was not present and was not returned for analysis.Moreover, the extrusion portion had been torn where the ro marker was supposed to be.Functional analysis was not performed due to the device condition.The reported complaint was not confirmed.Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification is operational context.A review of the device history record (dhr) was performed and no deviations were found.
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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 failed to extend and retract.The procedure was completed with this 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 a reportable event based on the investigation results; ro marker detached.
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