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Model Number M00534300 |
Device Problems
Break (1069); Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific that an advanix biliary stent and naviflex rx delivery system were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct, performed on (b)(6), 2023.During the procedure, the handle was found broken, and the release mechanism of the delivery system was not functioning properly.There was difficulty in deploying the stent and the stent and guide catheter were noticed to be broken near the sheath.The advanix biliary stent was implanted successfully in this procedure.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block g2: voluntary medwatch mdr report # mw5144789.Block h6: imdrf device code a0401 captures the reportable event of stent break and guide catheter break.
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Manufacturer Narrative
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Blocks b5 and h6 (device code) have been updated based on the additional information received on october 3, 2023.Updated b5 based on the additional information that was received from the complainant on october 03, 2023, that the handle/release mechanism was broken not the stent.Based on this new information, the manufacturer has determined this event no longer meets reporting criteria for the device in question.Block g2: voluntary medwatch mdr report # mw5144789.Block h6: imdrf device code a0401 captures the reportable event of stent break and guide catheter break.
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Event Description
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It was reported to boston scientific that an advanix biliary stent and naviflex rx delivery system were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct, performed on (b)(6) 2023.During the procedure, the handle was found broken, and the release mechanism of the delivery system was not functioning properly.There was difficulty in deploying the stent and the stent and guide catheter were noticed to be broken near the sheath.The advanix biliary stent was implanted successfully in this procedure.There were no patient complications reported as a result of this event.Additional information received on (b)(6) 2023: it
as reported that it was the handle/release mechanism that was broken and not the stent.
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Search Alerts/Recalls
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