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Model Number M00565120 |
Device Problems
Difficult to Remove (1528); Positioning Problem (3009)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 03/24/2022 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation on april 21, 2022 that a wallflex enteral colonic stent was to be implanted to treat a colon cancer during a colonoscopy with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the stent was unable to be reconstrained before reaching the reconstrainment limit mark.The stent was deployed proximal to the stricture.The stent was removed with difficulty using rat-tooth forceps and bleeding was noted.The bleeding has resolved on its own without any treatment and another wallflex enteral stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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