Model Number SGC0301 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported the device was discarded.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 being filed to report the leak in the steerable guide catheter.It was reported that during preparation of the steerable guide catheter (sgc), it was not able to hold column.The device was not used.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed tot he reported issue.Additionally, a review of the complaint history identified no other incidents reported for leaks from this lot.All available information was investigated and a definitive cause for the reported steerable guide catheter (sgc) leak (loss of fluid column during sgc preparation) could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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