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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 08/05/2021 |
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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the loss of fluid column.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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This is filed to report the steerable guide catheter (sgc) leak.It was reported that during preparation of the steerable guide catheter (sgc), the sgc failed to hold column, despite troubleshooting.The device was not used, there was no patient involvement.A new sgc was used to complete the procedure.There was no clinically significant delay to the intended procedure.No additional information was provided.
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Search Alerts/Recalls
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