MAUDE MDR 693061

MDR report key
693061
Report number
1018233-2006-00054
Event key
0
Event type
3
Date of event
2006-02-21
Date received
2006-03-27
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
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 BRACHYTHERAPHY IODINE 125 SEEDIODINE SEEDC.R. BARD, INC.KXKNAPS-1251CPSL67199YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-03-270

Event Narratives#

D

Patient 1

IT WAS INITIALLY REPORTED THAT AN IODINE SEED RUPTURED DURING A BRACHYTHERAPY SEED IMPLANT PROCEDURE. FOLLOW-UP WITH THE NUCLEAR MEDICINE TECHNICIAN REVEALED THAT THE APPLICATOR JAMMED DURING THE IMPLANT AND THE RADIATION ONCOLOGIST FORCEFULLY REMOVED THE CARTRIDGE FROM THE APPLICATOR. AFTER REMOVING THE CARTRIDGE, A SEED WAS FOUND STILL IN THE APPLICATOR AND THE DOCTOR FORCIBLY REMOVED IT. THE REMOVAL PROCESS COMPROMISED THE SEED AND RESULTED IN THE APPLICATOR BECOMING CONTAMINATED. FOLLOWING THE IMPLANT, REMOVABLE CONTAMINATION WAS FOUND ON THE APPLICATOR AND THE GENERAL WORK AREA. ALSO, FOLLOWING A CYSTOSCOPY, THE PATIENT'S BLADDER WAS FLUSHED AND METALLIC PIECES WERE FOUND IN THE FLUSHED URINE. THE URINE WAS SURVEYED AND FOUND TO BE RADIOACTIVE. SEVERAL DAYS LATER, A BIOASSAY WAS PERFORMED ON THE PATIENT AND THERE WAS A SMALL UPTAKE IN THE PATIENT'S THYROID LESS THAN 1 CGY (REM). THIS DOSE FALLS SHORT OF A MEDICAL EVENT AS OUTLINED IN 10CFR PART 35.3045 (A) (1). THE PATIENT WAS PRESCRIBED POTASSIUM IODINE AS A THYROID BLOCKER AND WILL REMAIN ON THIS FOR TEN DAYS. THE DOCTOR COULD FIND NO IODINE -125 REMAINING IN PATIENT'S URINE INDICATING CONTAMINATION CAME FROM THE RECOVERED COMPROMISED SEED AND NOT FROM AN IMPLANTED SEED.