FDA.reportPublic FDA data

MAUDE MDR 9873298

MDR report key
9873298
Report number
2134265-2020-03765
Event key
0
Event type
3
Date of event
2020-03-16
Date received
2020-03-24
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
TIMOTHY DEGROOT
Address
4100 HAMLINE AVENUE NORTH DC A330 SAINT PAUL MN 55112 US
Phone
651-651-6515
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETERCATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTERBOSTON SCIENTIFIC CORPORATIONOAD87047870470024773490R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-240

Event Narratives#

N

Patient 1

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

IT WAS REPORTED THAT HOLE IN THE CATHETER IRRIGATION TUBING WERE NOTED. . DURING AN ABLATION PROCEDURE TO TREAT VENTRICULAR TACHYCARDIA, AN INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER WAS SELECTED FOR USE. A HIGH TEMPERATURE ERROR MESSAGE WAS OBSERVED ON THE GENERATOR AND PREVENTED FURTHER ABLATION ATTEMPTS. UPON VISUAL EXAMINATION, A HOLE IN THE CATHETER IRRIGATION TUBING WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BOSTON SCIENTIFIC CATHETER OF THE SAME MODEL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.