FDA.reportPublic FDA data

MAUDE MDR 5347497

MDR report key
5347497
Report number
MW5058919
Event key
0
Event type
3
Date of event
2015-12-10
Date received
2015-12-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNEEDLE FOR PROSTATE SEED IMPLANTUNKIWJUNKUNKUNK* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-3101. O

Event Narratives#

D

Patient 1

DEVICE MISFIRE. THE NEEDLES WERE SUBSEQUENTLY PLACED THROUGH THE TEMPLATE IN THE APPROPRIATE POSITIONS BASED ON HIS PREOPERATIVE DOSIMETRY PLANNING. ALL SEEDS PLACED REALLY QUITE WELL WITH EXCEPTION OF ONE NEEDLE WHICH WOULD BE AT THE POSITON OF C2.0. WE HAD A NEEDLE FAILURE AND THE SEED COULD NOT BE PUSHED THROUGH THE NEEDLE. ULTIMATELY THESE TWO SEEDS WERE LOST. THIS WOULD BE A CAPSULAR NEEDLE PLACEMENT NEXT TO THE BACK WALL OF THE PROSTATE AND HOPEFULLY SHOULD POST NO PROBLEM FOR THE PATIENT. AT THE VERY END OF THE PROCEDURE, KUB FILM WAS TAKEN SHOWING EXCELLENT SEED PLACEMENT THROUGHOUT THE PROSTATE GLAND.