LEVEEN¿ STANDARD
Report
- Report Number
- 3005099803-2013-00197
- Event Type
- Malfunction
- Date Received
- January 16, 2013
- Date of Event
- December 28, 2012
- Report Date
- December 31, 2012
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- GEI
- PMA / PMN Number
- K982556
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- PHYSICIAN
Narratives
REPORTED EVENT: FAILURE TO ACHIEVE ROLL-OFF. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
DEVICE EVALUATION: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND NO ISSUES, AND THE TINES EXTENDED AND RETRACTED AS INTENDED DURING FUNCTIONAL TESTING. THE TINES WERE OBSERVED TO BE EVENLY SPACED AND PROPERLY FORMED. ELECTRICAL TESTING CONFIRMED THE DEVICE WAS ABLE TO CONDUCT CURRENT PROPERLY. THE COMPLAINT COULD NOT BE CONFIRMED; THE RETURNED DEVICE COULD NOT BE FUNCTIONALLY EVALUATED WITH RESPECT TO INSUFFICIENT ROLL-OFF WHILE IN USE. PER THE LEVEEN NEEDLE ELECTRODE FAMILY DIRECTIONS FOR USE, (DFU), "OCCASIONALLY, TISSUE IMMEDIATELY ADJACENT TO MULTIPLE, LARGE BLOOD VESSELS MAY NOT SHOW A SIGNIFICANT RISE IN IMPEDANCE, AND ALSO MAY SHOW LITTLE, IF ANY, CHANGE IN TISSUE WITH APPROPRIATE IMAGE MONITORING DUE TO THE OVERWHELMING HEAT-SINK EFFECT OF LOCALIZED BLOOD FLOW. IF THERE HAS BEEN LITTLE TO NO RISE IN IMPEDANCE AFTER 15 MINUTES HAVE ELAPSED, DETERMINE WITH THE APPROPRIATE IMAGING METHOD THE LOCATION OF THE TINES OF THE ELECTRODE IN RELATION TO A REGION OF HIGH VASCULARITY (E.G., BLOOD VESSELS). IF APPROPRIATE, REPOSITION THE ELECTRODE APPROXIMATELY 0.5 CM (5 MM) PROXIMAL OR DISTAL TO THE REGION OF HIGH VASCULARITY PRIOR TO RESUMING THE APPLICATION OF RADIOFREQUENCY (RF) ENERGY INTO THE TISSUE." BASED ON THIS INFORMATION, THIS EVENT IS CONSIDERED AN ANTICIPATED PROCEDURAL COMPLICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN STANDARD ELECTRODE WAS USED DURING RADIOFREQUENCY ABLATION (RFA) OF A FOCAL HEPATIC LESION PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, NO CHANGE IN IMPEDANCE WAS NOTED DURING THE FIRST 15-MINUTE ABLATION INTERVAL. THE GENERATOR WAS RESTARTED AND ANOTHER 15-MINUTE INTERVAL WAS PERFORMED WITH THE SAME POWER SETTING; HOWEVER, ONCE AGAIN NO CHANGE IN IMPEDANCE WAS NOTED. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER LEVEEN STANDARD ELECTRODE AND ROLL-OFF WAS ACHIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN STANDARD ELECTRODE WAS USED DURING RADIOFREQUENCY ABLATION (RFA) OF A FOCAL HEPATIC LESION PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, NO CHANGE IN IMPEDANCE WAS NOTED DURING THE FIRST 15-MINUTE ABLATION INTERVAL. THE GENERATOR WAS RESTARTED AND ANOTHER 15-MINUTE INTERVAL WAS PERFORMED WITH THE SAME POWER SETTING; HOWEVER, ONCE AGAIN NO CHANGE IN IMPEDANCE WAS NOTED. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER LEVEEN STANDARD ELECTRODE AND ROLL-OFF WAS ACHIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25093 | LEVEEN¿ STANDARD | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | BOSTON SCIENTIFIC - SPENCER | M001262130 | 15070407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |