BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT,METALLIC,EXPANDABLE,DUODENAL
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Model Number M00555860 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was contaminated and will not be returned for analysis; 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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Event Description
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It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex duodenal stent was to be implanted in the first part of the duodenum to treat a 10 mm over 2 cm malignant duodenal stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, when the wallflex duodenal stent delivery system was deployed halfway, there was no movement of the outer sheath that releases the stent.Then the wallflex duodenal stent suddenly deployed prematurely.The stent was removed from the patient with the use of rescue combo forceps.Another wallflex duodenal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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