Catalog Number SGC0302 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/07/2019 |
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 device 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 leak.It was reported that during preparation of the steerable guide catheter (sgc), loss of column was noted.The device was not used in the anatomy and was replaced.A new sgc was used to complete the procedure.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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Evaluation summary: all available information was investigated, and the reported leak was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported.Additionally, a review of the complaint history identified no similar incident reported from this lot.All available information was investigated and a definitive cause for the reported leak 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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