(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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This report is filed as a leak was noted in the steerable guide catheter during use.It was reported that this was a mitraclip procedure treating degenerative mitral regurgitation grade 3+.The steerable guide catheter (sgc) was advanced to left atrium (la) and was observed close to the lateral wall of the la.The sgc was retracted approximately 1 centimeter until the tip was no longer in contact with the la, per imaging.During clip delivery system (cds) insertion, there was no unusual resistance noted, however, a loss of sgc fluid column was observed and air was noted in the sgc hemostatic valve.As troubleshooting, additional aspiration was performed.The sgc air aspiration attempts were unsuccessful, however, there was no air noted in the patient anatomy.The sgc was removed and another sgc was successfully used in replacement.The same cds was advanced through the new sgc without issue and ones mitraclip was implanted, reducing the mr to <1.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided regarding this issue.
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