It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.An xt clip was inserted; however, during grasping while simultaneously actuating the grippers, one of the grippers would not lower.Troubleshooting was performed, but the issue was unable to be resolved.Therefore, the clip was removed and replaced.While outside the anatomy, the one gripper was unable to lower.The procedure was continued, and two new clips were successfully implanted, 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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All available information was investigated and the reported gripper actuation issue was 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 determined the reported gripper actuation issue appears to be due to the gripper line getting caught on the frictional element.However, a cause for how the gripper line getting caught cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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