This report is being filed because the device was returned with the hemostasis valve bond broken, which has the potential to cause or contribute to serious patient injury.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.After placement of the steerable guide catheter (sgc), the clip delivery system (cds) could not be advanced into the sgc even with troubleshooting.The same cds was used with a new sgc to successfully complete the procedure, with mr reduced to 2, no reported adverse patient effects, and no reported clinically significant delay in the procedure.There was no additional information provided.The sgc was returned with the hemostasis valve bond broken.
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