FDA.reportPublic FDA data

MAUDE MDR 9807535

MDR report key
9807535
Report number
2134265-2020-02639
Event key
0
Event type
3
Date of event
2020-01-24
Date received
2020-03-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
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 CORPORATIONDXO890089000024177380Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-090

Event Narratives#

N

Patient 1

THE PRODUCT WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF AN FFR COMET PRESSURE WIRE CONNECTED TO THE OCC CABLE. THE TIP, DEVICE SHAFT, SENSOR PORT AND THE COEFFICIENT VALUES WERE EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE DEVICES SHAFT SHOWED THREE KINKS LOCATED 42.5CM, 96CM AND 165CM FROM THE TIP. THE TIP SHOWED A KINK. THERE WAS SOME PEELED COATING AT THE 42.5CM AND THE 96CM LOCATION. THE OCC HANDLE WAS CONNECTED TO THE FFR LINK TO VERIFY THE SIGNAL STRENGTH. THE SIGNAL WAS PRESENT AS DESIGNED. 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 PRESSURE WAVEFORM TO THE POLARIS WHICH INDICATES A FUNCTIONING WIRE. THE WIRE WAS REMOVED FROM THE OCC HANDLE WITH NO ISSUES. THE SENSOR PORT SHOWED NO RESIDUE OF BODY FLUIDS. 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 ON 04MAR2020. IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. WHILE A COMET PRESSURE GUIDEWIRE WAS BEING USED DURING THE PROCEDURE, THE PRESSURE SIGNAL WAS LOST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.