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Model Number M00565030 |
Device Problems
Failure to Advance (2524); Difficult to Advance (2920); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed 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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Event Description
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It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex enteral duodenal stent was to be implanted to treat a malignant stricture in the duodenum from pancreatic mass during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the guidewire was unable to advance through the stent delivery system.A different stiffer guidewire was attempted but again the guidewire was unable to advance through the stent delivery system.The physician preloaded the stent into the scope with the guidewire; however, the delivery system was unable to advance and cross the stricture.The procedure was not completed and will be rescheduled where a shorter scope will be used.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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