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 was unable to determine a cause for the reported leak.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.
|
This is filed to report the air in the device.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).The steerable guide catheter (sgc) was advanced to the left atrium.After the dilator was removed from the sgc, air was noted adjacent to the hemostatic valve.Device aspiration was performed to remove the air, but this was not successful.The sgc was removed from the patient and replaced with a new one.The procedure continued and one mitraclip was implanted reducing mr grade to 1.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.
|