Model Number SGC0701 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was discarded.Investigation has not yet been completed.A follow-up report will be submitted with all additional relevant information.
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Event Description
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This will be filed to report the touhy of the steerable guide catheter was leak.It was reported that during preparation of the steerable guide catheter (sgc), it was observed that the touhy had a crack and was leaking.A new sgc was used in the procedure.There was no patient involvement and no clinically significant delay in the procedure.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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated and a cause for the reported crack and leak could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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Event Description
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Subsequent to the initial report filing, additional information reported that the crack was suspected and not confirmed.No additional information was provided.
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Search Alerts/Recalls
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