It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure on (b)(6) 2024.The procedure was performed under monitored anesthesia care (mac) and fiducials were placed transperineally.During the procedure the needle was inadvertently placed into the prostate capsule and then repositioned.A computed tomography (ct) was performed and a foley catheter was placed.During simulation, it was noted the gel was partially in the correct location, and some hydrogel had entered the prostate capsule, and moved around the prostate.After the procedure, the patient experienced discomfort and the feeling of fullness.The patient will proceed with planned treatment.
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