This is filed to report the torn steerable guide catheter (sgc 80111u127) soft tip.
It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.
The steerable guide catheter (sgc 80111u124) was advanced into the femoral vein, but resistance was noted.
The +/- knob was turned three fourths of a turn to straighten the guide, but the sgc could not be advanced and was removed.
It was observed that the sgc tip was not responding in minus direction and a cable break was suspected.
A new sgc (80111u127) was advanced successfully.
The first clip was implanted, reducing mr to 2.
The second clip delivery system (cds 80108u208) was advanced.
Visualization and grasping were difficult due to the anatomy.
The cds.
Was retracted, but became entangled in the chordae.
Troubleshooting was performed and the clip was freed.
The cds continued to be retracted, but met resistance with the sgc.
The cds was pulled hard and a pop was heard.
The clip detached from the cds and remained attached to the gripper and lock lines.
The clip was caught on the tip of the sgc; therefore, the entire system was retracted together.
The clip then caught on the septum.
The clip was freed, but the atrial septal defect (asd) was enlarged due to the clip interaction.
During removal of the system, resistance was felt with the femoral vein.
After removal, it was observed that the sgc soft tip was torn.
An asd occluder was used to treat the asd.
One clip was implanted, reducing the mr to 2.
No additional information was provided.
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(b)(4).
The device was returned for evaluation and the reported steerable guide catheter (sgc) torn soft tip was confirmed.
A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the event.
Additionally, a review of the complaint history identified no similar incidents reported from this lot.
The reported tear in the soft tip appears to be related to user technique/procedural conditions as a result of the clip getting caught on the guide 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.
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