(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other steerable guide catheter (80924u146) device referenced is filed under a separate medwatch report number.
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This is filed to report a leak.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.During preparation of the first steerable guide catheter (sgc 80723u203) while inserting the dilator, a leak was observed.Preparation was attempted five times, but the sgc continued to leak.The sgc was not used in the patient, and was replaced.The second sgc (80924u146) was advanced to the mitral valve.Next the first clip delivery system (cds) was advanced and it was noted that the patients oxygen level dropped.The oxygen level was controlled by the anesthesiologist.The procedure was continued, and the clip was deployed.As the cds was being removed, a shunt in both directions was observed.The physician stated the drop in oxygen level was associated to the shunt.A second clip (80905u147) was advanced to the mitral valve to further reduce mr; however, the clip would not open smoothly when the lock lever was pulled to position of the blue line and the lock line was loose.Trouble shooting was performed, and the clip was able to open.The clip was deployed and the cds was removed.The shunt was treated with an atrial septal defect (asd) closure device.Two clips were implanted, reducing mr to 1.There was no clinically significant delay in the procedure.No additional information was provided.
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Internal file number - (b)(4).Evaluation summary: the device was returned.All available information was investigated, and the reported leak was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported.Additionally, a review of the complaint history identified no lot-specific product quality issue from this lot.The discrepancy between what was reported (leak) and what was observed (no leak) is likely due to a user technique while inserting the dilator or not following the steps outlined in the instruction of use (ifu) during the device prep versus the returned product analysis contributed to the reported leak; however, this cannot be confirmed.All available information was investigated and a definitive cause for the reported leak could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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