(b)(4).
Evaluation summary: the sgc was returned and investigated.
The returned device analysis observed a torn soft tip.
A review of the lot history record revealed no manufacturing nonconformities.
Additionally, a review of the complaint history identified no similar incidents reported from this lot.
The mitraclip instructions for use states that the mitraclip nt system is intended for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
All available information was investigated and the observed torn soft tip was due to procedural conditions as the clip was not able to be closed during removal which caused the clip frictional elements to get caught on the soft tip, resulting in the identified tears in the soft tip.
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 is filed under a separate medwatch report number.
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This is filed to report the torn tip.
It was reported that this was a mitraclip procedure to treat severe tricuspid valve regurgitation (tvr).
The clip delivery system (cds) was advanced to the tricuspid valve.
During positioning, the clip was inverted to be retracted to the right atrium, but became caught on chordae.
Standard troubleshooting was performed, and the clip was freed successfully, with no damage.
An attempt was then made to close the clip, but the clip would not close and was stuck open at 60 degrees.
At this point, it appeared that the clip was separated from the mandrel, and was hanging loosely at the end of the cds.
The cds was removed with the gripper and lock lines left in place.
A snare was used to flip the clip so its end was pointing into the steerable guiding catheter (sgc).
There was some resistance noted with the tip of the sgc as the clip was in an open position.
The sgc was then retracted to the groin, with the clip just at the guide tip.
A partial cut down procedure was performed and the clip was successfully removed.
It was suspected that the sgc tip was torn due to the interaction with the clip, but this was not confirmed.
Additionally, after the clip was removed, it was suspected that the harness was missing.
No further clips were attempted and the procedure was discontinued.
The patient remains stable.
No additional information was provided.
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