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Model 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 11/28/2022 |
Event Type
malfunction
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Event Description
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This is filed to report a leak.It was reported that during preparation, when inserting the dilator into the steerable guide catheter (sgc), the column filled with air.This occurred multiple times; therefore, the sgc was not used and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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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 lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported leak.There is no indication of a product issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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