Catalog Number 22443-19 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that a hair was seen inside the sealed plastic pouch of the emboshield nav6 embolic protection system.The device was not used and there was no patient involvement.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was returned for evaluation.The reported issue of foreign material found in the sealed pouch was confirmed.A review of the electronic lot history record (elhr) for the reported lot revealed no nonconforming material records (ncmrs) were generated.A query of the complaint-handling database indicated there were no similar incidents reported from this lot for this issue.In this case, there were no untoward patient effects since the device was not used on a patient and the issue was detectable prior to the procedure.Based on the information reviewed for this lot, it was determined that this was an isolated incident and not representative of the entire lot.This type of reported event will continue to be monitored per local quality system procedures.
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Search Alerts/Recalls
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