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 08/31/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported the device was discarded and is not returning.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 fluid column leak in the steerable guide catheter.It was reported that this was a mitraclip procedure to treat grade 4 mitral regurgitation (mr).During device preparation of the steerable guide catheter (sgc), when the dilator was inserted in the sgc, the hemostatic valve would not hold the fluid column.The stopcocks were replaced and the dilator was re-inserted into the sgc, but the issue persisted.This was not used in the patient.Another sgc was prepared without incident and was successfully used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information 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 identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported leak (loss of fluid column).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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