FDA.reportPublic FDA data

MAUDE MDR 9786496

MDR report key
9786496
Report number
2134265-2020-02108
Event key
0
Event type
3
Date of event
2020-01-15
Date received
2020-03-04
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
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMETTRANSDUCER, PRESSURE, CATHETER TIPBOSTON SCIENTIFIC CORPORATIONDXO890089000023907359Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-040

Event Narratives#

N

Patient 1

DEVICE RETURNED TO MANUFACTURER: THE COMET WAS RETURNED AND ANALYSIS WAS COMPLETED. THE TIP, DEVICE SHAFT, SENSOR PORT AND THE COEFFICIENT VALUES WERE EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE WIRE SHOWED TWO KINKS LOCATED AT 176.5CM AND 180CM FROM THE TIP. THE TIP SHOWED BENDS. THERE WAS PEELED COATING AT THE 176.5CM LOCATION. THE OCC HANDLE WAS CONNECTED TO THE FFR LINK TO VERIFY THE SIGNAL STRENGTH. THE SIGNAL WAS PRESENT AS DESIGNED. THE SENSOR PORT SHOWED NO RESIDUE OF BODY FLUIDS. THE OCC HANDLE WAS THEN CONNECTED TO THE BENCH TOP TESTING EQUIPMENT AND THE WIRE WAS INSERTED INTO THE PRESSURE CHAMBER. THE PRESSURE WAS INCREASED TO VERIFY THE SENSOR WAS INDEED REACTING TO THE PRESSURE INCREASES AND DECREASES. THE PRESSURE SENSOR FUNCTIONED AS DESIGNED. THE COEFFICIENT VALUES WERE CONFIRMED TO BE PROGRAMMED. THE OCC HANDLE WAS AGAIN CONNECTED TO THE FFR LINK. THE DEVICE WAS THEN CONNECTED TO THE POLARIS (ILAB) TEST EQUIPMENT VIA BLUETOOTH SIGNAL. THE WIRE COMMUNICATED TO THE POLARIS SYSTEM AND ZEROED AS DESIGNED. THE WIRE WAS INSERTED INTO THE TEST PRESSURE CHAMBER AND THE WIRE TRANSFERRED A PD PRESSURE WAVEFORM TO THE POLARIS WHICH INDICATES A FUNCTIONING WIRE. THE WIRE WAS REMOVED FROM THE OCC HANDLE WITH NO ISSUES. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

D

Patient 1

REPORTABLE BASED ON ANALYSIS COMPLETED 14 FEB 2020. IT WAS REPORTED THAT THE COMET PRESSURE GUIDEWIRE WAS BENT. THIS COMET PRESSURE GUIDEWIRE WAS SELECTED HOWEVER, A 3CM PORTION OF THE TIP BECOME BENT. THEY TRIED TO RESHAPE THE TIP, BUT THEY COULD NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.