LEVEEN COACCESS ELECTRODE SYSTEM

Additional Manufacturer Narrative

THE PRODUCT WAS RETURNED FOR ANALYSIS, BUT DUE TO THE CONDITION OF THE DEVICE WAS RETURNED IN THE DEVICE COULD NOT BE DECONTAMINATED OR EVALUATED. THE TWO COMPLAINT DEVICES (FOR THIS REPORT AND ASSOCIATED MFR. REPORT # 3005099803-2009-2170) WERE RETURNED IN A SHARPS BUCKET THAT COULD NOT BE OPENED WITHOUT EXPOSING PERSONNEL TO A POTENTIAL SAFETY ISSUE. THE SHARPS BUCKET WAS OPENED ENOUGH TO FIND THAT MULTIPLE USED DEVICES AND A LARGE QUANTITY OF RESIDUE WAS RETURNED IN THE BUCKET. EVEN IF THE BUCKET COULD HAVE BEEN OPENED IT WOULD HAVE NOT BEEN KNOWN WHICH DEVICES WERE THE TWO COMPLAINT DEVICES. A FAILURE ANALYSIS COULD NOT BE PERFORMED DUE TO THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2009-2170 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED IN 2007 (MALE PATIENT; AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TYNES WOULD NOT DEPLOY INTO THE LEFT RENAL TUMOR AROUND THE HYLUM. THE SITE INDICATED THAT RETRACTING THE DEVICE WAS DIFFICULT. AFTER THREE UNSUCCESSFUL ATTEMPTS TO EXTEND THE DEVICE A SECOND LEVEEN COACCESS ELECTRODE SYSTEM WAS USED. NO COMPLICATIONS WERE REPORTED, HOWEVER, NUMEROUS ATTEMPTS TO ASCERTAIN FURTHER INFORMATION REGARDING THE PATIENT AND EVENT WERE UNSUCCESSFUL.