Model Number SGC0301 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported the device is not returning.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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This is filed to report the steerable guide catheter (sgc) failed to hold column during preparation.It was reported that during preparation of the steerable guide catheter (sgc) the hemostatic valve failed to hold column.The sgc was not used, there was no patient involvement.There was no additional information provided regarding this issue.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint identified no similar complaints reported from the lot.All available information was investigated and a cause for the reported leak/splash (loss of fluid column) could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.Na.
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Search Alerts/Recalls
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