Catalog Number SGC0705 |
Device Problems
Leak/Splash (1354); Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The mitraclips are submitted under separate manufacturer report numbers.
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Event Description
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This is being filed to report the sgc leak.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced and placed on the mitral valve.While removing the lock line, it was noted clip detached from the anterior leaflet (single leaflet device attachment (slda)).While preparing a second clip to stabilize the first one, the physician noticed that the steerable guide catheter (sgc) had unintentionally moved from the right atrium (ra) from the left atrium (la).The sgc was taken out and the physician performed all the transseptal steps from the beginning.But during the second preparation of the sgc the hemostatic valve did not hold column.After the third unsuccessful attempt to prepare the sgc it was discarded and a new sgc was used.A second cds was advanced however visibility was difficult due to the first clip.The clip was able to be implanted lateral to the first clip but after removing the sgc and the whole system from the patient, it was noted the second clip detached from the posterior leaflet.The procedure was completed with the mr reduced to 1-2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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The returned device analysis did not confirm the reported leak and the unintended movement.A review of the lot history identified no manufacturing nonconformities issued to the reported lot that would have influenced the reported issue.Additionally, a review of the complaint history did not identify any similar incidents.Based on the available information, a cause for the reported unintended movement and the leak could not be determined.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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