BOSTON SCIENTIFIC - GALWAY ULTRAFLEX? TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE
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Model Number UNK449 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an ultraflex¿ tracheobronchial stent was implanted to treat a malignant stricture during a bronchoscopy with stent placement procedure performed on an unknown date.According to the complainant, during the bronchoscopy with stent placement procedure, the ultraflex¿ tracheobronchial stent was fully deployed from the delivery system.Immediately following the stent placement, the physician noted that the stent had not fully expanded.The ultraflex¿ tracheobronchial stent was removed from the patient using a rigid scope with forceps.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry date.(b)(4).A visual and functional examination of the complaint device could not be performed since the device was disposed and not returned for analysis.The most probable root cause classification of this investigation is operational context.This is defined as a complaint that is associated with a product that meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.
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Search Alerts/Recalls
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