FDA.reportPublic FDA data

MAUDE MDR 9779695

MDR report key
9779695
Report number
9779695
Event key
0
Event type
3
Date of event
2020-01-22
Date received
2020-03-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FOGARTYCATHETER, EMBOLECTOMYEDWARDS LIFESCIENCES LLCDXE120803F120803F* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-030

Event Narratives#

D

Patient 1

WE ARE PERFORMING A FEMORAL POPLITEAL THROMBECTOMY AND USING #3 FOGARTY CATHETER, THE TIP OF THE CATHETER BROKE OFF IN THE PATIENT'S ARTERY.