FDA.reportPublic FDA data

MAUDE MDR 693086

MDR report key
693086
Report number
1018233-2006-00056
Event key
0
Event type
3
Date received
2006-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIVIAN STEPHENS, FIELD ASSUR MGR
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD BRACHYTHERAPY NEEDLEBRACHYTHERAPY NEEDLEC.R. BARD, INC.IWJNA818205REPF0639NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-03-2701. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A BRACHYTHERAPY IMPLANT PROCEDURE FOR PROSTATE CANCER, A NEEDLE BROKE AS IT WAS BEING RETRACTED AND THE PLUNGER WAS BEING PUSHED IN. THE DR. FELT A POP AND THE IMAGING SHOWED THAT THE NEEDLE WAS BROKEN. THE ULTRASOUND PROBE WAS REMOVED FROM THE PATIENT AND A SMALL INCISION WAS MADE IN THE PATIENT'S PERINEUM AND THE INDWELLING NEEDLE PIECE WAS REMOVED. EVEN THOUGH SOME OF THE NEEDLES HAD HIT BONE, THE DOCTOR DID NOT THINK THIS WAS ONE OF THEM. WHEN A NEEDLE HITS BONE, THE DOCTOR REMOVES THE NEEDLE, REPOSITIONS THE NEEDLE AND DOES NOT FORCE IT IF HE FEELS RESISTANCE. THERE WERE THREE SEEDS REMAINING IN THE PORTION OF THE NEEDLE THAT WAS REMOVED FROM THE PATIENT. THE NEEDLES FOR THE PROCEDURE HAD BEEN LOADED ON-SITE AT THE HOSPITAL BY THE CUSTOMER USING I-125 SEEDS. THERE WERE NO FURTHER COMPLICATIONS REPORTED.