LEVEEN COACCESS ELECTRODE SYSTEM
Received Aug 25, 2009 · Event occurred Jul 27, 2009
Report 3005099803-2009-03996 · MDR key 1708651
Device
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). 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: THIS REPORT PERTAINS TO ONE OF SIX COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MFR REPORT# 3005099803-2009-03997, 3005099803-2009-03998, 3005099803-2009-03999, 3005099803-2009-04000 AND 3005099803-2009-04001 FOR THE OTHER ASSOCIATED DEVICE INFO. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A RF 3000 RADIOFREQUENCY GENERATOR, A LEVEEN COACCESS ELECTRODE SYSTEM AND FOUR POLYHESIVE PT RETURN ELECTRODES WERE USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2009 (PT OVER 18 YEARS OLD). ACCORDING TO THE COMPLAINANT, AFTER THE PADS WERE ATTACHED TO THE FEMORAL REGION AND CONNECTED TO THE GENERATOR, THE LEVEEN NEEDLE WAS ADVANCED THROUGH TO THE TARGET LESION. THE NEEDLE WAS THEN CONNECTED WITH THE CABLE AND GENERATOR AND THE GENERATOR WAS POWERED ON. THE ABLATION WAS STARTED AT 30W. HOWEVER, AN "E03" ERROR (HIGH IMPEDANCE MEASURED) MESSAGE OCCURRED. THE GENERATOR WAS CYCLED OFF AND ON, HOWEVER, THE SAME INCIDENT OCCURRED. THE FOUR PADS WERE REATTACHED AND ALL CONNECTIONS WERE CHECKED. NO ANOMALY WAS NOTED WITH THE SETUP. THE GENERATOR WAS ONCE AGAIN CYCLED, HOWEVER, UPON RESTART, THE SAME ERROR MESSAGE WAS REC'D. THE PROCEDURE WAS COMPLETED WITH THE SAME RF 3000 RADIOFREQUENCY GENERATOR, ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM AND FOUR NEW POLYHESIVE PT RETURN ELECTRODES. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.