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Model Number M00565050 |
Device Problems
Difficult or Delayed Positioning (1157); Premature Activation (1484); Difficult to Remove (1528); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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The initial reporter's address: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex enteral colonic stent was implanted in between the sigmoid colon and the rectum to treat a 5cm malignant intestinal obstruction during a stent placement procedure performed on (b)(6) 2021.During the procedure, the stent was partially deployed; however, resistance occurred and the stent could not be fully deployed and recaptured.When the delivery system was removed, the stent deployed into the intestine.The stent could not be seen under the endoscope and could not be removed.Reportedly, the stent remains implanted and another wallflex enteral colonic stent was implanted to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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