This is filed to report tissue damage.It was reported that this was a degenerative mitral regurgitation (mr) with a grade 4.It was noted restricted - posterior.The transseptal puncture was performed without issue; however, while advancing the steerable guide catheter (sgc), the wire flipped out of the left upper pulmonary vein and curved to the left ventricle.The sgc was retracted to the right side of the heart.After a second crossover with the transseptal catheter, a structure was observed under the transseptal puncture.Imaging of the structure was not quite clear; however, after trying to find out where this structure was coming from, it was determined that there was possible tissue damage at the septum.Additional treatment was not performed.No clips were implanted, and mr is 4.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and a cause for the reported difficult positioning with the steerable guide catheter (sgc) cannot be determined.The tissue injury appears to be related to the procedural circumstances.Tissue damage is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.
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