Catalog Number CDS0705-XTW |
Device Problems
Difficult to Advance (2920); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant informationna.
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Event Description
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It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr) for a mitraclip procedure.It was noted that the grippers were able to actuate during device preparation.The clip delivery system (cds) was inserted into the steerable guide catheter (sgc), and there was resistance noted while aligning the blue marker band.The cds was advanced to the left atrium.At gripper orientation, it was noted that one gripper could not lower during simultaneous actuation.The clip was removed and replaced.Two clips were implanted and the mr was reduced to grade 1.There were no reported adverse patient effects or clinically significant delay.
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Manufacturer Narrative
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All available information was investigated and the reported difficult to advance (resistance while aligning the blue marker) and gripper actuation issue were not confirmed via returned device 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 difficult to advance and gripper actuation issue.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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