BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE
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Model Number M00564780 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/27/2022 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that an ultraflex tracheobronchial covered distal release stent was implanted in the bronchial tube to treat bronchial stenosis caused by malignant tumors in the lungs during a tracheobronchial stenting procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was deployed; however, tracheoscopy found that the distal stent wire was fractured and broken.The stent remains implanted and the procedure was completed with this device.On an unknown date, the broken stent was removed from the patient and a different stent was successfully implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: a photo of the complaint device was provided by the complainant and showed the stent wire was broken.
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was retained 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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