It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophageal varicose vein ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands could not be released.Reportedly, the ligator shrink wrap on the device was removed earlier in the setup process than as instructed in the device directions for use.There was no difficulty in setting up the device.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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