MOLLRING CUTTER

Description of Event or Problem

AFTER DEPLOYING THE CUTTING BLADES OF THE MOLLRING CUTTER, THE SURGEON CLOSED THE BLADES. THE BLADES DID NOT APPEAR TO FULLY CLOSE DURING FLUOROSCOPY, AND WHEN ATTEMPTING TO PULL THE MOLLRING CUTTER BACK IN ORDER TO REMOVE THE TRANSECTED PLAQUE CORE, THE FLUOROSCOPY INDICATED THAT ONE OF THE CUTTING BLADES HAD BROKEN OFF THE DEVICE, AND WAS STILL IN THE ARTERY. ANOTHER INCISION WAS MADE AND PLAQUE WAS REMOVED. THE PHYSICIAN USED AN ENDOHELIX DEVICE TO REMOVE THE MOLLRING BLADE. IT WAS THE PHYSICIAN'S FIRST TIME USING THE DEVICE, AND DEPLOYED THE WIRES BEHIND THE CORE RATHER THAN AROUND THE CORE. HE MADE ANOTHER ATTEMPT TO GO AROUND THE CORE, AND PERFORATED THE ARTERY WALL. THE INTERVENTIONAL RADIOLOGIST USED A STENT TO RESTORE THE FLOW, AND MADE THE RECOMMENDATION TO LEAVE THE MOLLRING BLADES IN THE ARTERY BECAUSE HE DOES NOT FORESEE ANY DANGER TO THE PT. PT IS DOING OKAY.

Additional Manufacturer Narrative

THE DEVICE WAS EVALUATED, AND WE WERE ABLE TO CONFIRM THAT DISTAL RING WAS DETACHED AND A CLEAN BREAK WAS SEEN. THE EVAL OF THE COMPLAINT DEVICE WAS INCONCLUSIVE ON THE ROOT CAUSE OF THE DEVICE FAILURE. THE DEVICE HISTORY RECORDS FOR LOT MOL1001 WAS EXAMINED. THE 100% INCOMING INSPECTION OF THE RING ALIGNMENT AND VISUAL INSPECTION FOR DAMAGE OR CRACKS WAS COMPLETED IN ACCORDANCE TO THE PROCEDURE WITH PASSING RESULTS. THIS IS THE FIRST COMPLAINT WE HAVE SEEN OF THIS IN 2008, THEREFORE, THIS IS AN ISOLATED INCIDENT. THIS IS THE INITIAL AND FINAL REPORT FOR THIS COMPLAINT. IF THERE IS ANY FURTHER INFO THAT IS FOUND CONCERNING THIS COMPLAINT, THIS WILL BE SENT IN A FOLLOW-UP REPORT.