SENSITHERM MULTI PROBE

Description of Event or Problem

FIAB S.P.A. RECEIVED A COMPLAINT REPORT FROM THE US DISTRIBUTOR ABOUT THE ESOPHAGEAL TEMPERATURE PROBE MODEL ST-PROBE-7 THE TEMPERATURE PROBE IS PLACED INTO PATIENT'S ESOPHAGUS BEFORE STARTING MEDICAL PROCEDURES THAT MAY IMPLY TEMPERATURE VARIATIONS, THE EVENT WAS ASSESSED BY FIAB AS A REPORTABLE EVENT ACCORDING TO THE DESCRIPTION PROVIDED BY THE DISTRIBUTOR, WHOSE FIELD REPRESENTATIVE WAS PRESENT IN THE EP ROOM DURING THE MEDICAL PROCEDURE: "AS THE CATHETERS WERE BEING REMOVED FROM THE BODY, THE CRNA NOTIFIED THAT THERE WAS A SUBSTANTIAL AMOUNT OF BLEEDING COMING FROM SOME UNKNOWN PLACE. THE CRNA WAS SUCTIONING THE BLOOD FROM THE PATIENT'S MOUTH. THERE WAS A SENSITHERM ESOPHAGEAL TEMPERATURE CATHETER IN PLACE AND IT WAS NOTED THAT THERE WERE SEVERAL ATTEMPTS AT THE BEGINNING OF THE PROCEDURE TO PLACE THE SENSITHERM CATHETER IN THE CORRECT LOCATION.THE CRNA REPOSITIONED THE CATHETER. I DID NOT WITNESS HER USING ANY LUBRICATION ON THE CATHETER. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, SHE USED THE INTUBATION BLADE TO HELP GUIDE HER VISUALLY AND THE CATHETER WAS SUCCESSFULLY PLACED IN A GOOD POSITION VERIFIED BY ELECTROGRAM SIGNALS. THE PATIENT HAD A NASAL SCOPE DONE BEFORE LEAVING THE PROCEDURE ROOM. THE FINDINGS WERE HIGHLY SUSPICIOUS FOR AN ESOPHAGEAL LACERATION. THE PATIENT WAS SENT TO HAVE A CT AND THIS FINDING WAS CONFIRMED. AFTER THE PATIENT WAS MOVED OUT OF THE PROCEDURE ROOM, DURING DISCUSSIONS, IT WAS STATED THAT THE PATIENT HAS A HISTORY OF ESOPHAGEAL STENOSIS THAT HAS REQUIRED DILATION IN THE PAST"

Additional Manufacturer Narrative

FIAB S.P.A. RECEIVED A COMPLAINT REPORT FROM THE US DISTRIBUTOR ABOUT THE ESOPHAGEAL TEMPERATURE PROBE MODEL ST-PROBE-7. THE LOT NUMBER OF THE DEVICE INVOLVED WAS NOT PROVIDED, THEREFORE THE FIELD D4 LOT NUMBER WAS FILLED AS "UNKNOWN" AND FIELDS D4 EXPIRATION DATE AND H4 MANUFACTURER DATE WERE LEFT EMPTY. THE TEMPERATURE PROBE IS PLACED INTO PATIENT'S ESOPHAGUS BEFORE STARTING MEDICAL PROCEDURES THAT MAY IMPLY TEMPERATURE VARIATIONS, THE EVENT WAS ASSESSED BY FIAB AS A REPORTABLE EVENT ACCORDING TO THE DESCRIPTION PROVIDED BY THE DISTRIBUTOR, WHOSE FIELD REPRESENTATIVE WAS PRESENT IN THE EP ROOM DURING THE MEDICAL PROCEDURE: "AS THE CATHETERS WERE BEING REMOVED FROM THE BODY, THE CRNA NOTIFIED THAT THERE WAS A SUBSTANTIAL AMOUNT OF BLEEDING COMING FROM SOME UNKNOWN PLACE. THE CRNA WAS SUCTIONING THE BLOOD FROM THE PATIENT'S MOUTH. THERE WAS A SENSITHERM ESOPHAGEAL TEMPERATURE CATHETER IN PLACE AND IT WAS NOTED THAT THERE WERE SEVERAL ATTEMPTS AT THE BEGINNING OF THE PROCEDURE TO PLACE THE SENSITHERM CATHETER IN THE CORRECT LOCATION.THE CRNA REPOSITIONED THE CATHETER. I DID NOT WITNESS HER USING ANY LUBRICATION ON THE CATHETER. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, SHE USED THE INTUBATION BLADE TO HELP GUIDE HER VISUALLY AND THE CATHETER WAS SUCCESSFULLY PLACED IN A GOOD POSITION VERIFIED BY ELECTROGRAM SIGNALS. THE PATIENT HAD A NASAL SCOPE DONE BEFORE LEAVING THE PROCEDURE ROOM. THE FINDINGS WERE HIGHLY SUSPICIOUS FOR AN ESOPHAGEAL LACERATION. THE PATIENT WAS SENT TO HAVE A CT AND THIS FINDING WAS CONFIRMED. AFTER THE PATIENT WAS MOVED OUT OF THE PROCEDURE ROOM, DURING DISCUSSIONS, IT WAS STATED THAT THE PATIENT HAS A HISTORY OF ESOPHAGEAL STENOSIS THAT HAS REQUIRED DILATION IN THE PAST" BASED ON THE INFORMATION AVAILABLE IT IS CONCLUDED THAT THE DEVICE FIAB ESOPHAGEAL TEMPERATURE PROBE IS NOT DIRECTLY LINKED TO THE INJURY SUFFERED BY THE PATIENT'S (ESOPHAGEAL LACERATION). ACTUALLY, THE DAMAGE REPORTED TO THE PATIENT WOULD RATHER SEEM TO BE CAUSED BY REPEATED AND INSISTENT ATTEMPTS AT ESOPHAGEAL INSERTION OF THE PROBE DESPITE THE DIFFICULTIES ENCOUNTERED AND ABOVE ALL WITHOUT TAKING INTO ACCOUNT THE PATIENT'S MEDICAL HISTORY, I.E. THE PRESENCE OF A PRE-EXISTING ESOPHAGEAL STENOSIS THAT HAS REQUIRED DILATION IN THE PAST, WHICH SHOULD HAVE IMMEDIATELY MADE IT CLEAR THAT THE INSERTION COULD BE DIFFICULT AND SUGGESTED TO THE CRNA TO STOP SO AS NOT TO CAUSE LESIONS. ACCORDING TO THE CLINICAL EVALUATION REPORT OF THE DEVICE MAINTAINED BY FIAB IN ITS TECHNICAL FILE, CASES OF ESOPHAGEAL LESIONS DURING THE INSERTION PROCEDURE HAVE NOT BEEN PREVIOUSLY REPORTED, NEITHER ON THE SPECIFIC FIAB DEVICE NOR IN THE LITERATURE ON SIMILAR / EQUIVALENT DEVICES, HOWEVER, BY VIRTUE OF THE CURRENT REPORTING, THE WARNINGS IN THE SENSITHERM MULTI PROBE IFU WILL BE REVISED TO ADD THE CONTRAINDICATION TO THE INTRODUCTION INTO THE ESOPHAGUS IN CASE OF PREVIOUS ESOPHAGEAL STENOSIS.