FDA.reportPublic FDA data

MAUDE MDR 9578687

MDR report key
9578687
Report number
3009437315-2020-00001
Event key
0
Event type
3
Date of event
2019-12-14
Date received
2020-01-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. FRED PIAZZA
Address
14 INVERNESS DRIVE EAST SUITE H-136 ENGLEWOOD CO 80112 US
Phone
303-303-3039
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1S-CATH ESOPHAGEAL TEMPERATURE PROBEESOPHAGEAL TEMPERATURE PROBECIRCA SCIENTIFICFLLCS-2001CS-2001R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-1001. R

Event Narratives#

N

Patient 1

NO SPECIFIC TESTING COULD BE PERFORMED ON THE COMPLAINT PROBE AS IT HAD BEEN DISCARDED BY THE HOSPITAL. A PROBE FROM RELEASED STOCK WAS EVALUATED BY VISUAL INSPECTION AND DIMENSIONAL MEASUREMENT. THE TIP IS ROUNDED AND SMOOTH WITH NO DEFECTS OBSERVED. PROBE AND STYLET DIMENSIONS WERE MEASURED AND ALL WERE WITHIN SPECIFICATION. STYLET WAS FULLY INSERTED AND PROBE WAS FLEXIBLE WITH NO INDICATION OF UNDUE STIFFNESS. A REVIEW OF PROBE SPECIFICATIONS AND ENGINEERING CHANGES SHOW NO CHANGES TO THE PROBE MATERIALS, DIAMETERS, THICKNESS, ETC. BASED ON EVALUATION OF SAMPLE FROM RELEASED STOCK AND ENGINEERING CHANGE REVIEW, THERE IS NO PRODUCT CHANGE OR DEFECT THAT WOULD ATTRIBUTE TO THE ESOPHAGEAL PERFORATION. CLEVELAND CLINIC COMMUNICATED THAT THE SITUATION WAS LIKELY DUE TO UNUSUAL FINDING OF PATIENT'S ESOPHAGUS. PHYSICIAN HAS SEEN THE IMAGES TAKEN DURING THE PROCEDURE AND SAID THAT THE ESOPHAGUS APPEARED TO HAVE AN FOLDS IN THE ESOPHAGUS. IT WAS DESCRIBED IN A WAY TO INDICATE THAT THIS WAS AN UNUSUAL FINDING. PATIENT MAY ALSO HAVE HAD A DOUBLE LUMEN.

D

Patient 1

ESOPHAGEAL PERFORATION. PATIENT UNDERWENT SURGERY AND WAS TREATED WITH AN ESOPHAGEAL STENT. ESOPHAGUS HAD TWO HOLES, DESCRIBED BY PHYSICIAN AS BEING ABOUT 8F AS IF THE PROBE HAD GONE OUT OF THE ESOPHAGUS AND THEN BACK INTO THE ESOPHAGUS. CIRCA USED TO MONITOR TEMPERATURE DURING A CARDIAC ABLATION PROCEDURE ABOUT 2 WEEKS PRIOR. THERE WAS NO THERMAL INJURY TO THE ESOPHAGUS.