It was reported to boston scientific corporation on august 18, 2022 that an unknown jagwire was used with a wallflex enteral colonic stent (the subject of manufacturer report # 3005099803-2022-05145) to treat a malignant stricture in the sigmoid colon during a colonoscopy procedure performed on (b)(6), 2022.The patient's anatomy was not tortuous.During the procedure, a scope was initially placed then the jagwire guidewire was put through and was advanced to the obstruction.The wallflex enteral colonic stent was put over the jagwire and pushed through the obstruction along with the scope.The physician then removed the scope and attempted to deploy the stent with 100% fluoroscopy.Post procedure, the patient abdomen looked distended.Colonoscopy was performed and perforation was noted above the stricture.Surgery was done on the same day to close the perforation.The patient was fully recovered at the end of the procedure.Note: in the physician's assessment, the jagwire could not be ruled out as possibly related to the perforation but also that the perforation was likely related poor visualization of the stricture as the wallflex stent was advanced to the stricture over the jagwire without endoscope visualization.
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