This is being filed to report a steerable guide catheter gas leak during the procedure.It was reported that a patient presented with grade 4+ mixed mitral regurgitation (mr).During a mitraclip procedure, the steerable guide catheter (sgc) was prepared per instructions for use (ifu) and inserted into the anatomy with not issue.As the clip delivery system (cds) was advanced into the sgc, air was introduced into the sgc.Attempts were made to aspirate the sgc, but air continued to enter.Upon further evaluation, it was noted that the side port was cracked, letting in air.Both the sgc and cds were removed and discarded.Air never entered into the anatomy.A replacement sgc and a mitraclip ntw were used to continue the procedure.Imaging was challenging, and the leaflets were thought to have been sufficiently grasped.Once the ntw was deployed, the anterior leaflet was lost and a single leaflet device attachment (slda) of the posterior leaflet occurred.A third mitraclip was implanted medial to the ntw, and successfully stabilized the slda.The mr was reduced to grade 1.There was no adverse patient sequelae or indication of a clinically significant delay.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 did not indicate a lot-specific quality issue.The investigation determined the reported leak (air was introduced into the sgc) appears to be related to the reported cracked side port/luer.A cause for the crack cannot be determined.The reported unexpected medical intervention was a result of case-specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.
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