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Model Number M00565010 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/25/2022 |
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 a wallflex duodenal stent was implanted to treat a malignant stricture in the ascending part of the duodenum during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was noted to be tortuous/tight and was accessed using a pediatric colonoscope.During the procedure, the stent deployed prematurely at an incorrect location.The physician re-positioned the stent into the correct location with the use of forceps.The wallflex duodenal stent remains implanted and the procedure was completed.There were no patient complications 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.(b)(4).The complainant indicated that the stent remains implanted 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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