This is filed to report difficult removal of the sgc.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.Patient had an enlarged atrium.The steerable guide catheter (sgc) was inserted, but during advancement, the sgc became stuck and was unable to advance further.The sgc was removed and a new sheath and guidewire were inserted.The sgc was then reinserted and was able to advance into the left atrium (la).However, while in the la, it was noted the sgc was difficult to advance and remove.The clip delivery system (cds) was in the la as well and it was noted the clip did not move while applying the a/p knob.The physician then decided to adjust the height of the lift.This allowed the clip to be correctly positioned.The clip was then successfully implanted, reducing mr to a grade of 2.Once the sgc was removed from the anatomy, it was observed to be kinked.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 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 failure to advance.The reported kink on the steerable guide catheter (sgc) shaft appears to be due the failure to advance.The kink on the shaft resulted in the difficulty removing the device.There is no indication of a product issue with respect to manufacture, design, or labeling.
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