THD EVOLUTION US
Received Mar 1, 2014 · Event occurred Feb 26, 2014
Report 3006680097-2014-00001 · MDR key 3680040
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Death
Narrative
Additional Manufacturer Narrative
BASED ON A CONVERSATION BETWEEN (B)(6) SALES REP AND THE ANESTHESIOLOGIST OF THE SECOND THD CASE, THE PT WAS KNOWN TO HAVE HEART PROBLEMS. (B)(6). THD SPA MADE THREE ATTEMPTS TO DIRECTLY CONTACT THE DOCTOR AND GATHER FIRST HAND RELATED INFO: FIRST ATTEMPT - (B)(4) 2014 4:35PM (CET), (B)(4), AT THE PRESENCE OF (B)(4)). DR. (B)(6) WAS BUSY WITH PTS AT THE (B)(6). SECOND ATTEMPT - (B)(4) 2014 5:15PM (CET),(B)(4), AT THE PRESENCE OF (B)(4). DR. (B)(6) WAS BUSY WITH PTS AT THE (B)(6). THIRD ATTEMPT -(B)(4) 2014 (EST), (B)(4), DR. (B)(6) WAS NOT AVAILABLE.
Description of Event or Problem
DURING A SCHEDULED THD CASE, REGULARLY PROCEEDING, THE SURGEON WAS WARNED BY THE ANESTHESIOLOGIST ABOUT A HEART PROBLEM RELATED TO THE PT. THE THD CASE WAS SUSPENDED SINCE CHEST COMPRESSION PROCEDURE WAS INITIATED TO SUPPORT THE PT. NEVERTHELESS, THE PT DIED. THE SURGEON REFERRED THAT THE DEATH WAS NOT CAUSED BY THE THD CASE. FIFTY MINUTES LATER, A SECOND SCHEDULED THD CASE STARTED AT THE SAME FACILITY WITH ANOTHER SURGEON. THIS SECOND CASE WAS SUCCESSFULLY TERMINATED.