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Model Number SGC0701 |
Device Problems
Difficult to Flush (1251); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.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 the steerable guide catheter air leak.It was reported that this was a mitraclip procedure performed to treat grade 4+ mixed mitral regurgitation (mr).The patient has scoliosis and curves in the vena cava.The steerable guide catheter (sgc) was advanced into the left atrium.Air was observed in the sgc, the sgc could not be aspirated.The tip of the sgc was not up against the wall, nothing was blocking the sgc tip.The sgc was retracted to the inferior vena cava but again the sgc could not be aspirated.There was no damage observed and no thrombus.Air did not enter the patient.The sgc was removed and was replaced.One clip was implanted, reducing mr to 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.The sgc was tested outside of the anatomy, the sgc was flushed without issue.No additional information was provided.
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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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported leak/splash and difficulty to flush of the steerable guide catheter (sgc).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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