LEVEEN COACCESS ELECTRODE
Received Nov 25, 2009
Report 3005099803-2009-05604 · MDR key 1557323
Device
Manufacturer
Boston Scientific CorporationModel number
M001262230Catalog number
26-223
Lot number
12860811
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4) - (INSUFFICIENT ROLL-OFF). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFO IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
Description of Event or Problem
NOTE: THE DATE OF EVENT IS UNK. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2009-05605 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN COACCESS ELECTRODE WERE USED DURING A LUNG RFA PROCEDURE (PATIENT OVER 18 YEARS OLD). ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS TO BEGIN WITH THE GENERATOR POWER SET TO 50 WATTS. HOWEVER, ROLL-OFF OCCURRED PRIOR TO REACHING THE 50 WATTS. THE CONSOLE WAS RESET, BUT AT 20 WATTS, MAXIMUM ROLL-OFF WAS RECEIVED. 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.