LEVEEN COACCESS ELECTRODE SYSTEM

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A TUMOR ABLATION PROCEDURE PERFORMED IN 2007 (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER INSERTING THE DEVICE INTO THE PATIENT, THE TINES WOULD NOT FULLY EXTEND. THE PHYSICIAN FURTHER INDICATED THAT THE TINES WERE TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

Additional Manufacturer Narrative

NO CONSEQUENCES OR IMPACT TO PATIENT. DEPLOY, FAILURE TO. TWISTING. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE ARRAY WAS ALMOST FULLY EXTENDED AND WAS SEVERELY TWISTED. THE PROXIMAL 1.5 CENTIMETERS OF THE ARRAY WAS TWISTED APPROXIMATELY 180 DEGREES. A FUNCTIONAL EVALUATION FOUND THAT EXCESS FORCE WAS NEEDED TO RETRACT AND EXTEND THE ARRAY DUE TO THE TWIST. A BEND WAS IDENTIFIED IN THE ELECTRODE, 9.5 CENTIMETERS FROM THE DISTAL END OF THE ELECTRODE HANDLE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE TINES WERE TWISTED AND WOULD NOT FULLY EXTEND. THE MOST PROBABLE ROOT CAUSE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.