The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and without the device to analyze, a cause of the reported gripper line break could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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This is filed to report gripper line break.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4 and dilated left atrium.A mitraclip xtw was used, but while manipulating the clip in the left ventricle (opening and closing of the clip), one of the gripper lines broke.Therefore, the mitraclip was removed from the patient.Another mitraclip xtw was implanted to complete the procedure.The procedure was completed with one clip implanted.The mr was reduced to trace.There was no clinically significant delay in the procedure.No additional information was provided.
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