FDA.reportPublic FDA data

MAUDE MDR 426954

MDR report key
426954
Report number
6000002-2002-00423
Event key
0
Event type
3
Date of event
2002-09-25
Date received
2002-11-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ALLISON MEZZANATTO
Address
ONE EDWARDS WAY IRVINE CA 92614 US
Phone
949-949-9492
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVANCED VENOUS ACCESS HIGH FLOW DEVICECENTRAL VENOUS ACCESS DEVICEEDWARDS LIFESCIENCESJCYM3L9FSNA941LC763K981909NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-11-0501. L

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PT EXPERIENCED HEMORRHAGIC SHOCK DURING CENTRAL VENOUS PLACEMENT OF THE DEVICE AT THE RIGHT INTERNAL JUGULAR VEIN. IT WAS STATED THAT HEMOSTASIS DURING THE OPERATION WAS PROBLEMATIC. THE PT HAD A HEMOTHORAX WITH A3 LITER BLOOD LOSS. NO FURTHER PT ISSUES WERE REPORTED AS A RESULT OF THIS EVENT.