Catalog Number CDS0706-XTW |
Device Problems
Break (1069); 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 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.An xtw clip was prepared per the instructions for use (ifu) and inserted without issues.It was noted that the anterior leaflet was caught on the anterior gripper during grasping.Troubleshooting was performed and the was able to be freed without causing any tissue damage.While grasping, 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.Upon removal, it was observed one of the gripper lines was no longer visible.Three clip 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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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 gripper actuation issue and gripper line break were confirmed via returned device analysis.The reported difficult or delayed positioning (anterior leaflet was caught on the anterior gripper during grasping) could not be replicated in a testing environment as it was related to patient/procedural conditions or operational circumstances.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 no similar complaints reported from this lot.The investigation determined the reported gripper actuation issue appears to be related to the gripper line break.A conclusive cause for the gripper line break and gripper caught on anterior leaflet (difficult or delayed positioning) cannot be determined.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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