Catalog Number CDS0705-NTW |
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 02/08/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant informationna.
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Event Description
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It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade unk.A ntw mitraclip was chosen for implantation and advanced to the left atrium.During gripper orientation, one of the grippers could not lower.Troubleshooting was attempted but was unsuccessful.A replacement device was used to complete the procedure.Gripper function was normal during preparation.After being removed from the anatomy, the gripper still would not lower.There were no patient consequences or clinically significant delay.
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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 did not indicate a lot-specific quality issue.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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