(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
(b)(4).
The customer reported the device was discarded.
Investigation is not yet complete.
A follow up report will be submitted with all additional relevant information.
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This is filed to report the torn soft tip, perforation and medical intervention.
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) was advanced into the femoral vein, but resistance was felt.
Force was applied, but the sgc tip became bent and torn.
The sgc was removed to be replaced; however, bleeding was observed at the puncture site.
An unspecified covered stent was deployed to treat the perforation.
The procedure was continued.
One clip was implanted, reducing mr to 1-2.
There was no clinically significant delay in the procedure.
No additional information was provided.
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