This report is filed for the foreign substance found in the hemostatic valve of the steerable guide catheter (sgc) which required aspiration to remove the substance.It was reported that the first mitraclip was successfully deployed.The clip delivery system (cds) was removed from the steerable guide catheter (sgc) and the sgc was flushed and aspirated per normal procedures.A foreign substance, suspected to be a thread, was seen inside the hemostatic valve of the sgc.The substance was aspirated out and a second cds was used with the same sgc, without incident.Mitral regurgitation (mr) was reduced from grade 4 to trace with implantation of two clips.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
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(b)(4).Evaluation summary: the steerable guide catheter (sgc) and clip delivery system (cds) were both returned and investigated.The suspected thread was found in the cds as it was reportedly aspirated from the sgc into the cds.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated, and a definitive cause for the reported thread inside the sgc could not be determined.It is likely that the foreign material was introduced during the procedure, as it was not originally observed during device unpackaging and preparation.Furthermore, the account reported it is possible that the thread came from sterile cloth or compress; however, this cannot be definitively confirmed.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.
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