Catalog Number CDS0702-XTW |
Device Problem
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 04/02/2024 |
Event Type
malfunction
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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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Event Description
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It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4, flail, and prolapsed leaflets.An xtw clip was prepared per the instructions for use (ifu) and inserted without issues.It was noted after a few grasping attempts, it was observed that one gripper was not functioning as intended.Therefore, the clip was removed and replaced.Three clips were 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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All available information was investigated, and the reported single gripper actuation issue was confirmed via returned device analysis.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 did not indicate a lot-specific quality issue.Based on available information and the returned device analysis, the cause of the observed gripper line is unable to be determined.The reported single gripper actuation issue was likely a cascading event of the observed broken gripper line.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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