FDA.reportPublic FDA data

MAUDE MDR 462273

MDR report key
462273
Report number
MW1028506
Event key
0
Event type
3
Date of event
2003-05-22
Date received
2003-05-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
404
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GALILEO IIISOURCE DELIVERY UNITGUIDANTMOU***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-05-270

Event Narratives#

D

Patient 1

AT 6 PM ON THE DAY OF EVENT, USER ADVANCED SOURCE TO ARTERY AND THE SOURCE STOPPED IN PATHWAY. THEY IMMEDIATELY PERFORMED THE EMERGENCY RESPONSE PROCEDURE ACCORDING TO THE MFR RECOMMENDATIONS IN THE USER MANUAL. THE ACTIVE SOURCE WAS RETRACTED IN THE CARTRIDGE. NO PT PROBLEM.