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Model Number M00513750 |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 mdr will be filed.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal ng distal release covered stent was to be used to treat a stenosis caused by tumor during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent was successfully placed in the stenosis.Reportedly, when re-entering the esophagus for post-placement inspection, two wires at the proximal end of the stent were confirmed loose.The stent was removed from the patient and the procedure was not completed.There were no patient complications reported as a result of this event.Note: despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
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Manufacturer Narrative
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A deployed ultraflex esophageal ng stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was unraveled.The stent was measured to be within specifications.No other issues were noted to the stent.The reported event of stent unraveled was confirmed.The investigation concluded that procedural factors encountered during the procedure or the technique of the user, could have affected the device performance.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record ( dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of released for distribution.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal ng distal release covered stent was to be used to treat a stenosis caused by tumor during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent was successfully placed in the stenosis.Reportedly, when re-entering the esophagus for post-placement inspection, two wires at the proximal end of the stent were confirmed loose.The stent was removed from the patient and the procedure was not completed.There were no patient complications reported as a result of this event.Note: despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
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Search Alerts/Recalls
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