Model Number SGC0301 |
Device Problems
Break (1069); Unstable (1667)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/05/2020 |
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.
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Event Description
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This is filed to report a broken hemostatic valve.It was reported that during preparation, the hemostatic valve of the dilation would not hit a hard stop and continued to turn.The dilator and steerable guide catheter (sgc) were not used and were replaced.There was no clinically significant delay in the procedure.No additional information was provided.
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Event Description
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Subsequent to the initially filed report, the following information was received: the issue was with the hemostatic valve cap.No additional information was provided.
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Manufacturer Narrative
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All available information was investigated, and the reported unstable rotating hemostatic valve (rhv) cap was not confirmed via returned device 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 similar complaints reported from this lot.All available information was investigated and a cause for the reported unstable rhv cap could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.H6: device code 1069 removed and code 1667 added.
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Search Alerts/Recalls
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