Catalog Number SGC0301 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the clip 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 filed to report the loss of fluid column.It was reported that during preparation, the steerable guide catheter (sgc) failed twice.The hemostatic valve would not hold fluid column.The device was not used and was replaced.There was no significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no lot-specific product quality issue 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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