This is filed to report the steerable guide catheter air leak.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.When inserting the mitraclip delivery system (cds) into the steerable guide catheter, air was seen in the hemostasis valve of the steerable guide catheter (sgc).Continuous aspiration was applied however the air did not stop.Air did not enter the patient.The sgc was removed and was replaced.One clip was implanted, reducing mr to <1.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
|
The device was returned for analysis.The reported leak (loss of fluid column) could not be confirmed/tested via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint.Additionally, a review of the complaint history identified no other complaints.All available information reviewed, and a cause for the reported steerable guide catheter (sgc) leak could not be determined.The discrepancy between what was reported (loss of fluid column/air in hemostasis valve) and what was observed (no issues) appears to be due to procedural condition/user technique, however this could not be confirmed.The additional therapy/non-surgical treatment was a result of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.
|