Catalog Number CDS0706-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 01/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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All information was investigated, and the returned device analysis confirmed the reported single gripper actuation issue.Additionally, it was noted that the gripper line was broken.The reported difficult or delayed positioning - anatomy could not be replicated in a testing environment.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated, and while the reported single gripper actuation issue appears to be related to the observed gripper line break, a cause for how the gripper line broke could not be determined.Difficult or delayed positioning associated with the clip interacting with the anatomy appears to be related to patient anatomy (flailed leaflet).There is no indication of a product issue with respect to manufacture, design or labeling.
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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 4.An xtw clip was prepared per the instructions for use (ifu) and inserted without issues.However, while under the valve, it was observed that one gripper was not functioning as intended.Troubleshooting was performed, but the issue was unable to be resolved.Therefore, the clip was removed and replaced.Two clips were then deployed, reducing mr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.
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Search Alerts/Recalls
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