BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE
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Model Number M00576530 |
Device Problems
Break (1069); Difficult to Remove (1528); Unraveled Material (1664); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2022 |
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 to be implanted to treat a malignant stricture in the left main stem of the lung during a tracheobronchial stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was misdeployed and the stent location could not be confirmed under live fluoroscopy due to anatomical or procedural circumstances.During removal of the delivery system, the stent was dislodged into the trachea.The stent was removed from the patient with forceps.During removal of the stent, the stent was unraveled and the stent suture was broken.The procedure was not completed due to availability of the device.There were no patient complications reported due to this event.A photo provided by the complainant of the device outside the patient showed the stent was unraveled and the stent suture was broken.
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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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