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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 10/13/2021 |
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 the reported issue.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on available information, a cause of the reported leak cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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This is filed to report during preparation, the sgc failed to hold water column.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.During preparation of the steerable guiding catheter (sgc), it was observed that the hemostatic valve didn't hold the water column.It seemed that the valve had a leak.After multiple attempts and changing stop cocks, the issue continued.A new sgc was used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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