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Model Number M00513840 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that an ultraflex esophageal ng proximal release covered stent was to be implanted during a bronchoscopy with stent placement procedure performed on an unknown date.During the procedure, the stent "misfired".The procedure was completed with another ultraflex esophageal stent.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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Approximated based on the date the manufacturer became aware of the event.Medical device problem code: (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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Search Alerts/Recalls
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