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Model Number M00553650 |
Device Problems
Device-Device Incompatibility (2919); Migration (4003)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/27/2020 |
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 manufacture and expiration dates are unknown.However, it was reported that the device was not used past its expiry date.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure 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 july 03, 2020 that a hot axios stent was implanted in a transgastric position to treat a pancreatic cyst during a cyst drainage procedure performed on (b)(6) 2020.According to the complainant, on (b)(6) 2020, a necrosectomy procedure was performed and the stent got caught by the forceps and was dislodged into the stomach.The stent was removed using forceps.Reportedly, the cyst has not yet resolved and a plastic stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.Reportedly, the patient is under observation because the cyst had not resolved at the time the hot axios was dislodged into the stomach.
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Search Alerts/Recalls
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