(b)(4).Investigation results: visual evaluation of the returned rx cytology brush revealed that blue touhy-borst cap was completely unthreaded from the t-fitting threads.The blue cap, steel and zytel stop washers, and silicone gland were all present on the thumb ring hypotube and the t-fitting.Blue cap and t-fitting threads were not damaged.Residues were found on the device which indicate use and handling.The pull wire broke from the distal end of the thumb ring hypotube.The bristled portion of the brush was within specification.Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification for the reported failure 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.
|
It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the wire next to the orange thumb ring broke when brush was extended.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 good.This event has been deemed a reportable event based on the investigation results; pull wire broken.
|