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Model Number M00565060 |
Device Problem
Activation Failure (3270)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/16/2022 |
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 problem 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) 2022 that a wallflex colonic stent was to be implanted in the colon to treat cancer during a colonic stenting procedure performed on (b)(6) 2022.During the procedure, the stent failed to open.The stent was removed from the patient and the procedure was completed with another wallflex colonic stent.A non-serious injury was reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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Block h6: medical device problem code a150101 captures the reportable event of stent failure to expand.Block h10: a wallflex enteral colonic stent was received for analysis; the delivery system was not returned.Visual inspection found the stent was in good condition and was fully expanded.No issues with the stent were noted.The reported event of stent failure to expand could not be not confirmed as the stent was received fully expanded.Taking all available information, there is no indication of what the customer reported because the stent was returned fully expanded and the stent had no damages.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Event Description
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It was reported to boston scientific corporation on (b)(6), 2022 that a wallflex colonic stent was to be implanted in the colon to treat cancer during a colonic stenting procedure performed on (b)(6), 2022.During the procedure, the stent failed to open.The stent was removed from the patient and the procedure was completed with another wallflex colonic stent.A non-serious injury was reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Search Alerts/Recalls
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