LARIAT RS SUTURE DELIVERY DEVICE

Additional Manufacturer Narrative

THE COMPLAINT WAS CONFIRMED - THE SNARE RELEASE MECHANISM INSIDE THE HANDLE WAS ACTUATED, BUT THE CATCH AND THE DISTAL END OF THE LOCK WIRE REMAINED IN PLACE, ATTACHED TO THE TIP.

Description of Event or Problem

A PATIENT UNDERWENT LARIAT LEFT ATRIAL APPENDAGE MANAGEMENT (LAAM) PROCEDURE FOLLOWED BY PFA ABLATION. DURING THE LAAM PROCEDURE, THE LARIAT DELIVERY SYSTEM DID NOT FUNCTION AS INTENDED AS EVIDENCED BY FAILURE OF SNARE TO DISENGAGE FOLLOWING ACTIVATION OF SUTURE FOB. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE, AND THERE WAS NO IMPACT ON PATIENT CARE OR CLINICAL OUTCOME. NO ADVERSE EVENT OCCURRED WITH THE USAGE OF THIS PRODUCT. HOWEVER, THIS EVENT DESCRIBES A PRODUCT MALFUNCTION THAT IF IT WERE TO RECUR MAY HAVE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THEREFORE, PURSUANT TO 21 CFR 803 WE ARE SUBMITTING THIS MEDWATCH REPORT.