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Catalog Number SGC0701 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.Based on information provided and without the device to analyze, a cause for the reported leak/splash (loss of fluid column during device preparation) could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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Event Description
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It was reported that during preparation of a steerable guide catheter (sgc), while inserting the dilator, a loss of fluid column occurred.Troubleshooting was performed but was not successful.Therefore, the sgc was not used and was replaced.There was no clinically significant delay in the procedure.
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Search Alerts/Recalls
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