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 observed harness pinching the gripper cover; however, a cause for the pinched cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted.To further reduce mr, an additional xtw clip was prepared per the instructions for use (ifu) and inserted without issues.However, while in the valve, it was observed that one of the gripper was not functioning as intended.Troubleshooting was performed, but the issue was unable to be resolved.Therefore, the clip was removed and replaced.Two clips 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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