Device evaluation: the everflex entrust stent delivery system, (sds), was received for evaluation within a sealed tyvek pouch, within a sealed biohazard pouch, and loosely coiled within a red plastic biohazard pouch tied shut.No ancillary devices from the procedure were received for evaluation.The entrust was received with the outer sheath retracted and the inner guidewire lumen/pusher exposed.The deployment handle was examined: the silver outer sheath is visible over the inner guidewire lumen in the safety tab cavity.Approximately 12.6cm of the inner guidewire lumen is exposed.The printed strain relief was removed from the deployment handle to allow further examination of the handle.The handle was split opened, the pull cable was fully wrapped around the thumbwheel, and the silver outer sheath proximal end was advanced proximal to the pulley.The pull cable to outer sheath bond was broken.The pull cable to outer sheath tensile strength bond is equal to or greater than 8.0lbs.The pull cable most likely separated from the outer sheath after stent deployment and after the outer sheath was fully retracted into the handle based on the damage to the outer sheath.If information is provided in the future, a supplemental report will be issued.
|