FDA.reportPublic FDA data

MAUDE MDR 3913385

MDR report key
3913385
Report number
2953686-2014-00007
Event key
0
Event type
3
Date of event
2014-04-15
Date received
2014-06-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
INNETTA WALKER
Address
2603 CAMINO RAMON STE 100 SAN RAMON CA 94583 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COBRA FUSION 150 ABLATION SYSTEMCOBRA FUSION 150 ABLATION SYSTEMENDOSCOPIC TECHNOLOGIES, AN ATRICURE COMPANYOCL700-001MI700-001MI-KUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-1001. D

Event Narratives#

D

Patient 1

PATIENT UNDERWENT AN ABLATION PROCEDURE. THE PROCEDURE WENT WELL AND THE PATIENT WAS IN SINUS RHYTHM AT THE END OF THE PROCEDURE. THE FOLLOWING MORNING, THE PATIENT HAD A DENSE STROKE AND WAS FOUND TO HAVE A LARGE CEREBRAL HEMATOMA ON CT. THE PATIENT, DURING THE DAY, BECAME PROGRESSIVELY SICKER WITH CEREBRAL EDEMA AND CLONE.

N

Patient 1

DEVICE HISTORY RECORD OF ALL DEVICE LOTS SOLD TO HOSPITAL WERE REVIEWED - NO ISSUES WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE DEVICE WAS NOT RETURNED. ACCORDING TO DISCUSSIONS DURING THE INVESTIGATION, THE PATIENT MAY NOT HAVE BEEN GIVEN THE PROPER ANTI-COAGULATION MEDICINE.