This is filed to report the loss of fluid column during device preparation.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4+.During device preparation of the steerable guide catheter (sgc), there was loss of fluid column as soon as the dilator was inserted into the sgc.There was no patient involvement, and it was exchanged for a new sgc.The procedure began and one clip delivery system (cds 10816r117) was advanced and placed medially on the mitral valve.During deployment, after the clip was released from the cds, it opened to 25 degrees.However, the clip remained stable on the leaflets and the mr was reduced to a grade of 2+.A second cds (11014r259) was advanced to the mitral valve, and it was noted that there was shadowing due to the cds.While in the ventricle, the clip got caught in the chords because there was not enough height in the left atrium which made it hard to navigate.Standard troubleshooting was performed to maneuver the device back into the left atrium.However, it is believed to have caused a leaflet perforation.The physician proceeded with implanting the clip and it was deployed medially on a2/p2.After the clip detached from the cds it was noted to have opened to 20 degrees, but the clip remained stable on both leaflets and the procedure was complete.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.
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The returned device analysis did not confirm the reported leak.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported leak could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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