Catalog Number SGC0301 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/01/2019 |
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 sgc is expected to be returned for investigation.It has not yet been received.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) leak.It was reported that during preparation of the sgc, after the dilator was introduced, a loss of fluid column was observed.Trouble shooting was performed, but was unsuccessful.The sgc was not used in the anatomy and was replaced.The procedure was successfully completed with a new sgc.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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Internal file number - (b)(4).Evaluation summary: all available information was investigated and the reported leak issue was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the reported leak in this incident could not be determined in this incident.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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