ENSOETM
Received Apr 7, 2022 · Event occurred Feb 9, 2022
Report 3010412492-2022-00001 · MDR key 14048358
Device
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
75 YR · Female
- Hypervolemia
- Hypervolemia
Narrative
Additional Manufacturer Narrative
ATTUNE MEDICAL DETERMINED IT IS REASONABLE TO CONCLUDE THAT (1) IT IS UNLIKELY THE ENSOETM CONTRIBUTED TO THE PATIENT'S INTRAVASCULAR VOLUME IN A CLINICALLY SIGNIFICANT WAY, (2) THE ENSOETM DID NOT MALFUNCTION DUE TO ITS DESIGN OR MANUFACTURING PROCESSES, AND (3) THE LEAK IN THE ENSOETM WAS MOST LIKELY CAUSED BY A SHARP OBJECT LOCATED IN OR AROUND THE PATIENT'S MOUTH DURING PLACEMENT OR USE OF THE DEVICE.
Description of Event or Problem
THE PATIENT RECEIVED A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION ON (B)(6) 2022. AN ENSOETM WAS INSERTED TO THE COOL THE PATIENT'S ESOPHAGUS DURING THE PROCEDURE. THE DEVICE WAS INSPECTED FOR LEAKS PRIOR TO INSERTION, AND NO LEAKS WERE NOTED PRIOR TO INSERTION. AFTER INSERTION, A SMALL AMOUNT OF FLUID WAS NOTED IN THE PATIENT'S MOUTH. AT THIS TIME, THE ENSOETM WAS PARTIALLY REMOVED FROM THE ESOPHAGUS AND INSPECTED FOR LEAKS, AND A "SMALL TRICKLE" OF WATER WAS NOTED. HOWEVER, THIS FLUID WAS INITIALLY BELIEVED TO BE ORAL SECRETIONS FROM THE MOUTH AND THE ENSOETM WAS REPLACED. UPON RE-INSERTING THE ENSOETM IN THE ESOPHAGUS, MORE FLUID WAS NOTED IN THE PATIENT'S MOUTH, AND THE ENSOETM WAS AGAIN REMOVED AND INSPECTED FOR LEAKS. AT THIS TIME, A STEADY STREAM OF WATER WAS NOTED TO BE LEAKING FROM THE SIDE OF THE TUBE NEAR THE LOCATION ON THE DEVICE WHERE THE PATIENT'S MOUTH WAS LOCATED. THE LEAKING ENSOETM WAS REPLACED WITH A NEW ENSOETM, AND THE REMAINDER OF THE ABLATION PROCEDURE PROCEEDED WITHOUT INCIDENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS HELD IN THE HOSPITAL TO ALLOW A SUFFICIENT NUMBER OF HEMODIALYSIS SESSIONS TO RESTORE THE PATIENT TO THEIR OPTIMAL WEIGHT AND HEMODYNAMIC STATUS. THESE SESSIONS WERE PRE-PLANNED DUE TO THE PATIENT'S BASELINE CONGESTIVE HEART FAILURE, END STAGE RENAL DISEASE, AND MISSED HEMODIALYSIS SESSIONS, COMBINED WITH THE FLUID ADDED TO THE PATIENT'S CIRCULATION VIA THE IRRIGATION OF THE RADIOFREQUENCY CATHETER. FOLLOWING THE PRE-PLANNED HEMODIALYSIS SESSIONS, THE PATIENT WAS SUCCESSFULLY DISCHARGED IN GOOD CONDITION.