Description of Event or Problem · 1
THE EVENT OCCURRED AT A UNIVERSITY MEDICAL CENTER DURING A PROCEDURE CONDUCTED IN 2005. THIS ADVERSE EVENT INVOLVED DECREASED OXYGEN SATURATION LEVELS DURING THE PROCEDURE. THE ADVERSE EVENT REPORT WAS FILED BY THE SITE AND LISTED THE EVENT AS "ANTICIPATED". THERE WAS NO DISCUSSION IN THE EVENT REPORT OF ANY CAUSAL RELATIONSHIP BETWEEN THE PLICATOR DEVICE AND THE EVENT. ADDITIONALLY, IT WAS STATED BY THE PHYSICIAN THAT THE PT HAD HAD A HISTORY OF COMPROMISED AIRWAYS DURING PREVIOUS ENDOSCOPY PROCEDURES USING A SCOPE ONLY. THE PHYSICIAN / INVESTIGATOR WHO PERFORMED THE PROCEDURE INDICATED THAT THE SUBJECT WAS A PETITE WOMAN WITH A SMALL DIAMETER TRACHEA WHO HAD A HISTORY OF COMPROMISED AIRWAY BASED ON PREVIOUS ENDOSCOPY PROCEDURES. THE PHYSICIAN STATED HIS OPINION THAT THE PLICATOR DEVICE WAS NOT SOLELY RESPONSIBLE FOR THE REPORTED EVENT, BUT INDICATED THAT HE BELIEVED THAT THE PLICATOR'S FRENCH SIZE MAY HAVE CONTRIBUTED TO A DIMINISHED AIRWAY CAPACITY IN THIS PT BY IMPINGING ON THE TRACHEA. ALTHOUGH THE SUBJECT HAD THIS PROCEDURE UNDER GENERAL ANESTHESIA AND WAS THEREFORE INTUBATED, IT IS POSSIBLE THAT THE PLICATOR CONTRIBUTED TO THE PATIENT'S REDUCED OXYGEN LEVELS DURING THE PROCEDURE. IT SHOULD BE NOTED THAT THE PLICATOR PERFORMED CONSISTENT WITH EXPECTATIONS, THE IMPLANT WAS SUCCESSFULLY PLACED, THE PLICATOR DEVICE WAS REMOVED, PT OXYGEN LEVELS WERE RESTORED AND THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.