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Model Number M00565060 |
Device Problems
Entrapment of Device (1212); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Imdrf device code a1502 captures the reportable event of stent positioning issue.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral colonic stent was to be implanted to treat a malignant stricture during a colonic stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the physician had seen and confirmed stent deployment through fluoroscopy; however, post stent deployment, when the scope was brought for reprocessing cleaning process, it was noted that the scope was blocked and the wallflex enteral stent was found deployed inside the scope.It is unknown how was the stent removed from the scope.There were no patient complications reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation on december 01, 2022 that a wallflex enteral colonic stent was to be implanted to treat a malignant stricture during a colonic stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the physician had seen and confirmed stent deployment through flouroscopy even though two colonic stents were in situ from previous procedures, and visibility through the scope was difficult.Post stent deployment, when the scope was brought for reprocessing cleaning process, it was noted that the scope was blocked, and the wallflex enteral colonic stent was found deployed inside the scope.It is unknown how was the stent removed from the scope.There were no patient complications reported as a result of this event.Additional information received on december 22, 2022: no additional stent was placed, and the procedure was not completed.
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Manufacturer Narrative
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Blocks b5 and h6 (impact codes) have been updated with additional information received on december 22, 2022.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h11: block b5 has been corrected.
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Manufacturer Narrative
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Blocks b5 and h6 (impact codes) have been updated with additional information received on january 03, 2023.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral colonic stent was to be implanted to treat a malignant stricture during a colonic stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the physician had seen and confirmed stent deployment through flouroscopy even though two colonic stents were in situ from previous procedures, and visibility through the scope was difficult.Post stent deployment, when the scope was brought for reprocessing cleaning process, it was noted that the scope was blocked, and the wallflex enteral colonic stent was found deployed inside the scope.It is unknown how was the stent removed from the scope.There were no patient complications reported as a result of this event.**additional information received on december 22, 2022** no additional stent was placed, and the procedure was not completed.**additional information received on january 03, 2023** on an unknown date, the patient was brought back for a repeat procedure using another wallflex enteral colonic stent and the procedure was completed successfully.
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Search Alerts/Recalls
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