This is filed to report that the rotating hemostasis valve (rhv) was loose.It was reported that after the steerable guide catheter (sgc) and dilator were removed from the package, the preparation was started by attempting to close the rotating hemostasis valve (rhv) cap; however, the cap felt loose and then fell off when touched.It was not possible to replace the rhv cap on the dilator so a new device was opened.No portion of the mitraclip system was used in the anatomy and there was no clinically significant delay in the procedure.No additional information was provided regarding this issue.
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(b)(4).Evaluation summary: the clip delivery system was returned and investigated.The reported dilator cap detachment was confirmed; however, the instability of the cap was not confirmed.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 the instability and detachment of the dilator cap were related to improper user technique.The returned device analysis confirmed that the cap functioned as expected once it was pressed back onto the rotating hemostatic valve (rhv).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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