ENDORE MOLLRING CUTTER TRASECTION DEVICE

Additional Manufacturer Narrative

WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND CONFIRMED THE REPORTED INCIDENT. WE FOUND THAT WHEN THE DEVICE WAS CLOSED, THE TWO RINGS DO NOT OVERLAP OVER EACH OTHER AS ONE OF THE HOOP WAS FOUND TO BE SLIGHTLY BENT. AS A RESULT, WHEN REMOVING THE CORE, PHYSICIAN COULD HAVE EXPERIENCED DIFFICULTY/RESISTANCE WHEN PASSING THE RINGS THROUGH A NARROWER SECTION OF THE VESSEL. IT IS ALSO POSSIBLE THAT THE TORTUOUS ANATOMY OF THE PATIENT, CALCIFIED PLAQUE IF PRESENT IN THE PATIENT'S VESSEL AND EXCESSIVE TENSION ON THE DEVICE WHILE PULLING THE CORE COULD ALSO HAVE AIDED TO THIS FAILURE. AS STATED IN OUR IFU, THIS DEVICE IS NOT DESIGNED TO CUT CALCIFIED MATERIAL. ATTEMPTED TRANSECTION OF SUCH MATERIAL MAY DAMAGE THE MOLLRING CUTTER TRANSECTION DEVICE. WE HAVE CONDUCTED A LOT HISTORY REVIEW AND DID NOT FIND ANY ISSUES NOTED IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS ISSUE. ALL QC TESTS PASSED THEIR REQUIREMENTS. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF SIMILAR NATURE FOR DEVICES FROM THIS LOT. WE THEREFORE BELIEVE THIS IS AN ISOLATED INCIDENT. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. PHYSICIAN WAS ABLE TO RETRIEVE THE DEVICE AND THE ATHEROMATOUS CORE USING A LEMAITRE ENDOHELIX DEVICE.

Description of Event or Problem

DURING REMOTE ENDARTERECTOMY OF SFA, AFTER TRANSECTING THE ATHEROMATOUS CORE USING A MOLLRING CUTTER TRANSECTION DEVICE, PHYSICIAN TRIED TO EXTRACT THE CORE OUT FROM THE PATIENT'S VESSEL. HOWEVER, THE DEVICE WAS STUCK MIDWAY IN THE THIGH. PHYSICIAN THEN HAD TO USE ENDOHELIX RETRIEVAL DEVICE TO REMOVE THE CORE AND THE DEVICE FROM THE PATIENT'S VEIN.