Analysis of the returned rx cytology brush revealed multiple bends in the working length and the pull wire had become broken at the end of the hypotube.Brush was extended in position, and the blue cap and t-fitting threads were undamaged.The catheter had been cut by the user from the heat shrink.The event was most likely caused by some operational or anatomical aspect of the procedure which restricted the pull wire¿s ability to move freely within the catheter.Attempts to extend and retract the brush with pull wire movement restricted resulted in the broken pull wire.Therefore, the most probably root cause for this event is determined to be operational context.
|
It was reported to boston scientific corporation that an rx cytology brush was used in the bile duct during a biopsy procedure performed on (b)(6) 2015.According to the complainant, during the procedure the brush was inserted into the bile duct and moved the brush back and forth by manipulating the thumb ring.From the thumb ring, the device was separated at 2 cm.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 of pull wire broken.
|