It was reported to boston scientific corporation that a capio¿ slim device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, during deployment of the suture through the ligament, the needle detached from the suture and was left in the ligament.The procedure was completed with same capio¿ slim device and new capio suture.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 stable.
|