LEVEEN COACCESS ELECTRODE SYSTEM
Received Aug 20, 2009 · Event occurred Jul 22, 2009
Report 3005099803-2009-03947 · MDR key 1491947
Device
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
65 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MFR REPORT # 3005099803-2009-03946 FOR THE OTHER ASSOCIATED DEVICE INFO. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN COACCESS ELECTRODE SYSTEM WERE USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED IN 2009. ACCORDING TO THE COMPLAINANT, THE ABLATION BEGAN AT 40W AND WAS INCREASED 10W PER MINUTE. HOWEVER, THE PHYSICIAN INDICATED THAT THE IMPEDANCE WAS NOT STABLE AND ROLL OFF COULD NOT BE ACHIEVED. FURTHERMORE, AFTER SEVERAL ATTEMPTS, THE OUTPUT UNEXPECTEDLY INCREASED FROM 40W TO 70W. ON THE FOURTH ABLATION ATTEMPT AN ERROR CODE APPEARED, AT WHICH TIME THE SYSTEM WAS REBOOTED. AFTER THE RESET, THE PROCEDURE WAS COMPLETED WITH THE SAME RF 3000 RADIOFREQUENCY GENERATOR AND LEVEEN COACCESS ELECTRODE SYSTEM. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
Additional Manufacturer Narrative
INSUFFICIENT ROLL-OFF. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXP AND DEVICE MANUFACTURE DATES ARE UNK. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.