FDA.reportPublic FDA data

MAUDE MDR 3629195

MDR report key
3629195
Report number
MW5034481
Event key
0
Event type
3
Date of event
2014-01-24
Date received
2014-02-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAVI 8-1 CATHETERBREAST CATHETERCIANNA MEDICALJAQSAVI 8-1 R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-02-100

Event Narratives#

D

Patient 1

SAVI 8-1 BREAST CATHETER DEVICE HAS TWO OBSTRUCTED CHANNELS THAT WOULD NOT ALLOW THE PASSAGE OF THE HDR SOURCE TO DELIVER PLANNED RADIATION DOSE FOR BREAST CANCER TREATMENT. THE TREATMENT PLAN WAS RERUN ELIMINATING THE TWO OBSTRUCTED CHANNELS. A SATISFACTORY RADIATION DOSE DISTRIBUTION WAS ACHIEVED USING THE REMAINING CHANNELS. THE TREATMENT WAS DELAYED ONE DAY DUE TO THIS PROBLEM. REASON FOR USE: BREAST CANCER.