BOSTON SCIENTIFIC - GALWAY WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010; STENT,METALLIC,EXPANDABLE,DUODENAL
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Model Number UNK476 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/15/2016 |
Event Type
Injury
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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.However, the complainant reported that the device was not expired.(b)(4) stent positioning problem.The device has not been received for analysis.Upon receipt and completion of the failure 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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Event Description
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It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex enteral duodenal stent was to be implanted to treat a stricture caused by a mass in the colon during a colonoscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the stent was deployed outside of the intended location.The stent was deployed in the sigmoid area, half in the tumor and half above it.The technician mentioned that because the stent was not deployed in the stricture, there was no decompression of the bowel and the patient was instead sent to open surgery to decompress the patient's bowel on the same day.It was unknown if the stent was removed during the surgery.
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