N/A
Received Jan 7, 2011 · Event occurred Dec 6, 2010
Report 2090040-2011-00001 · MDR key 1953084
Product problems
- Shelf Life Exceeded
- Device Displays Incorrect Message
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE "CARTO III SYSTEM DISPLAYED A MESSAGE THAT THE ASCENT" ULTRASOUND CATHETER WAS EXPIRED. THE PROCEDURE TIME WAS EXTENDED 1.5 HOURS TO TROUBLE-SHOOT AND REPLACE THE DEVICE. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
THE COMPLAINT DEVICE WAS EVALUATED BY ASCENT. THE DEVICE PASSED ALL VISUAL INSPECTION AND FUNCTION TESTING. TO DETERMINE THE LAST TIME THE DEVICE WAS CONNECTED VIA THE HYPERTRONIC CONNECTOR, THE MEMORY DATA WAS EXTRACTED. THE MEMORY DATA SPECIFIED THAT THE LAST TIME THE DEVICE WAS CONNECTED VIA THE HYPERTRONIC CONNECTOR WAS (B)(6) 2010 AT 2:02 AM EASTERN TIME. THE DEVICE HISTORY REPORT FOR THE DEVICE WAS ALSO REVIEWED AND IT WAS DETERMINED THAT THE DEVICE WAS SUCCESSFULLY REPROGRAMMED ON (B)(6) 2010. DURING THE REPROGRAMMING PROCESS THE DEVICE'S PREVIOUS TIME STAMP IS EXPUNGED TO ALLOW FOR THE NEW TIME STAMP AND MEMORY INFORMATION TO BE RECORDED. AFTER THE DEVICE IS CONNECTED VIA THE HYPERTRONIC CONNECTOR, THERE IS A 24-HOUR WINDOW OF OPERATION IN WHICH THE DEVICE MUST BE USED BEFORE THE CONSOLE INDICATES THAT THE DEVICE HAS EXPIRED. DURING THE INVESTIGATION THE DEVICE WAS ALSO REPROGRAMMED TO ENSURE THAT THE DEVICE COULD BE ENCRYPTED AND READ. IT PASSED ALL MEMORY REPROGRAMMING TESTING. SINCE THE DEVICE WAS CORRECTLY PROGRAMMED WHEN LEAVING ASCENT AND COULD BE SUCCESSFULLY ENCRYPTED AND READ, THE COMPLAINT IS NOT CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THE "EXPIRED" ERROR MESSAGE IS THAT AFTER THE DEVICE LEFT ASCENT, BUT PRIOR TO THE TIME OF THE OPERATION, IT WAS CONNECTED VIA THE HYPERTRONIC CONNECTOR WHICH TIME STAMPED THE DEVICE. IF THE TIME BETWEEN WHEN THE DEVICE WAS CONNECTED AND THE START OF THE OPERATION SURPASSED 24 HOURS, THE CONSOLE WOULD INDICATE THAT THE DEVICE HAD EXPIRED. THIS IS THE FIRST COMPLAINT THAT ASCENT HAS RECEIVED FOR THE DEVICE BEING EXPIRED.
Additional Manufacturer Narrative
AT THE TIME OF THIS REPORT THE DEVICE INVESTIGATION HAS NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.