Catalog Number SGC0302 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.Na.
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Event Description
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This is being filed to report the leak in the sgc.It was reported that during preparation of the steerable guide catheter (sgc), the hemostatic valve lost column.Troubleshooting was performed without success therefore 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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All available information was investigated and the reported steerable guide catheter (sgc) leak was not confirmed during return device analysis as no issues were noted during testing.A review of the lot history record revealed no manufacturing nonconformities reported to this lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported leak could not be determined in this complaint.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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