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 02/23/2024 |
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 4.An xtw clip was prepared per the instructions for use (ifu) and inserted without issues.However, while in 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.It was noted that the clip was caught on a leaflet, no tissue damage.One clip was then deployed, mr remains a grade of 4.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 has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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All available information was investigated, and the reported single gripper actuation issue was confirmed via returned device analysis.The reported difficult positioning (clip caught on leaflet) could not be replicated in a testing environment.Additionally, a gripper line was observed to be broken.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.Based on available information, the cause of the reported single gripper actuation issue, difficult positioning (clip caught on leaflet), and observed broken gripper line were unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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