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 12/06/2023 |
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.Na.
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Event Description
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It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (fmr) with a grade of 3-4.One clip was successfully deployed on the mitral valve.To further reduce mr, an additional clip was inserted, but it was observed that one gripper was not functioning as intended.Therefore, the clip removed and was replaced.One additional clip was implanted reducing mr to a grade of <1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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All available information was investigated and the reported gripper actuation issue was 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 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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