(b)(4).
The sgc was returned and investigated and was noted to have a torn soft tip.
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.
The returned device analysis confirmed tears in the soft tip which is indicative of an interaction between the clip and guide tip during retraction.
All available information was investigated and a definitive cause for the identified tears in the soft tip could not be determined.
Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
The clip delivery system was filed under mfr report # 2024168-2017-05691.
|
This is filed to report the steerable guide catheter (sgc) soft tip tear.
It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.
Two clips were implanted without issue, reducing the mr to moderate.
The third clip delivery system (cds) was advanced for lateral placement, close to the commissure.
The leaflets were successfully grasped, but the clip failed to deploy.
The decision was made to remove the cds with the clip.
While retracting the clip into the sgc, the clip detached from the cds, inside the sgc.
There was no resistance noted within the sgc, and the clip was successfully removed with the cds.
Two clips were implanted, reducing the mr to 3.
The patient was confirmed to be stable post procedure.
There was no clinically significant delay in the procedure.
Returned device analysis found that the sgc soft tip was torn.
No additional information was provided.
|