Catalog Number CDS0702-XTW |
Device Problems
Difficult or Delayed Positioning (1157); 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 02/06/2024 |
Event Type
malfunction
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Event Description
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It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.An xtw clip was prepared per the instructions for use (ifu) and it was observed that the posterior leaflet was hanging on the gripper.Once removed, it was noted that one of the grippers were not functioning as intended.Therefore, the clip was removed and replaced.One clip was then deployed, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
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Manufacturer Narrative
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Returned device analysis did not confirm the reported single gripper actuation issue (difficult to open or close).Difficult or delayed positioning with anatomy could not be replicated in a testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.A review of the complaint history identified no similar complaints from the lot.Based on information provided and the results of the returned device analysis (unable to confirm the reported single gripper actuation issue), a cause for the reported difficult to open or close associated with a single gripper actuation issue during procedure resulting in the reported difficult or delayed positioning with anatomy cannot 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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