The device was not returned for 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 identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported leak (loss of fluid column).There is no indication of a product issue with respect to manufacture, design, or labeling.
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This is filed for leak.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.During preparation of a steerable guide catheter (sgc), it was noted that the column would not hold fluid during flushing.Therefore, the sgc was not used in the patient and the procedure continued with a new sgc.The new sgc was advanced to the mitral valve, and the first clip was implanted without issue.Then a second clip delivery system (cds) was advanced to the mitral valve; however, the clip could not grasp both leaflets due to insufficient height.Therefore, the cds was removed with the clip attached and the procedure ended at this point.One clip was implanted, reducing mr to 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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