(b)(4).A visual analysis revealed that the device was returned closed.The blue sheath overran the distal stop, affecting the devices' ability to open.The blue/green shrink on the distal end of the cone was missing and was not returned.Also, the white heat shrink was found accordioned at the proximal end.Since the complaint is associated with a product which met specifications but most likely encountered anatomical or procedural factors which limited its performance, the most probable root cause for this event is operational context.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
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It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a transurethral ureterolithotripsy (tul) procedure performed on an unknown date.According to the complainant, during the procedure, the coil of the stone cone failed to open.The procedure was completed by another of the same 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 "good." this event has been deemed a reportable event based on the investigation results; coil coating peeled.
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