BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE
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Model Number M00576670 |
Device Problems
Difficult to Advance (2920); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Approximated based on the date the manufacturer became aware of the event.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure 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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Event Description
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It was reported to boston scientific corporation on june 14, 2021 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a stricture during a bronchoscopy with stent placement procedure performed on an unknown date.During the procedure, the stent would not advance over the guidewire.The procedure was cancelled because another stent of the same size was not available.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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