LEVEEN COACCES ELECTRODE SYSTEM
Received May 27, 2009 · Event occurred Oct 22, 2007
Report 3005099803-2009-02163 · MDR key 1393498
Device
Generic name
Jos
Manufacturer
Boston Scientific Corporation-spencerModel number
M001262230Catalog number
26-223
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007 THAT A LEVEEN COACCESS ELECTRODE SYSTEM DEVICE WAS USED DURING A RADIO FREQUENCY ABLATION PROCEDURE (MALE PATIENT; AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, THE PHYSICIAN VERY DIFFICULT TO RETRACT THE INNER NEEDLE OF THE INTRODUCER SET. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD".
Additional Manufacturer Narrative
NO CONSEQUENCES OR IMPACT TO PATIENT. OTHER (DIFFICULTY RETRACTING). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.