Catalog Number CDS0706-NTW |
Device Problems
Difficult or Delayed Positioning (1157); Positioning Failure (1158); 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 04/04/2024 |
Event Type
malfunction
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Event Description
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It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4, restricted leaflets, and thick leaflets.The clip was insert and after repositioning the clip, the leaflets were unable to be grasped.While retracting the clip back into the left atrium (la), it was observed that the anterior was caught on the gripper.Troubleshooting was performed and the clip was able to be freed without causing damage.While grasping the leaflets again, it was noted that one gripper was not functioning as intended.Therefore, the clip was removed and replaced.One clip was 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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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.Additionally, the gripper line was observed to be broken.The reported unable to grasp leaflets and clip caught in anatomy could not be replicated in a testing environment.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 and the returned device analysis, the cause of the reported unable to grasp leaflets, clip caught in anatomy, and observed broken gripper line were unable to be determined.The reported single gripper actuation issue is 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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