MOLLRING CUTTER

Description of Event or Problem

THE MOLLRING CUTTER DEVICE WAS ADVANCED DOWN THE SUPERFICIAL FEMORAL ARTERY. UPON TRANSECTION, THE MOLLRING CUTTER TIP OR RING BROKE AND BECAME LOOSE WITHIN THE SUPERFICIAL FEMORAL ARTERY. ANOTHER MOLLRING DEVICE WAS USED TO GRASP THE TIP AND MOVED THE TIP FOR APPROXIMATELY 8CM. A FOGARTY CATHETER BALLOON WAS THEN USED TO REMOVE THE TIP COMPLETELY FROM THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT.

Additional Manufacturer Narrative

DURING A PROCEDURE INVOLVING A MOLLRING CUTTER, THE TIP OR RING BROKE AND BECAME LODGED WITHIN THE SUPERFICIAL FEMORAL ARTERY. THE RING WAS GRASPED WITH ANOTHER MOLLRING DEVICE AND ADVANCED 8CM TO ALLOW A FOGARTY BALLOON TO COMPLETELY REMOVE THE RING COMPLETELY FROM THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT. THE DEVICE WAS EVALUATED ON 1/2/2008. FROM OUR EVALUATION WE WERE ABLE TO CONFIRM THE REPORTED COMPLAINT. WHEN THE DEVICE WAS RETURNED, IT WAS CONFIRMED THAT THE PROXIMAL RING WAS DETACHED FROM THE DEVICE. THE DEVICE ARM WAS VERY DIFFICULT TO EXTEND. THE ROOT CAUSE OF THE DEVICE MALFUNCTION REMAINS INCONCLUSIVE AT THIS TIME. VASCULAR ARCHITECHS WAS ACQUIRED BY LEMAITRE VASCULAR INC. IN SEPTEMBER 2007. FOR THIS REASON, THIS REPORT IS BEING SUBMITTED BY LEMAITRE VASCULAR.