This is filed to report during the procedure, air volume was noted in the steerable guide catheter requiring aspiration.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.When the clip delivery system (cds) was introduced into the steerable guide catheter (sgc), air was introduced by the physician.There was no issue with the stopcocks, so the cds was withdrawn back into the introducer and additional aspiration was performed to de-air the sgc.However, when pulling the clip into the introducer, the clip got stuck.The clip was then unstuck and advanced back into the sgc, but for caution reasons, a new cds was used to complete the procedure with the same sgc.One clip implanted, reducing mr to 1+.There was no adverse patient effect 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 other complaints reported from this lot.The investigation determined the reported leak appears to be related to user technique.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.Na.
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