FDA.reportPublic FDA data

MAUDE MDR 504292

MDR report key
504292
Report number
1018233-2003-00047
Event key
0
Event type
3
Date of event
2003-11-30
Date received
2003-12-30
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, MANAGER
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 PLATINUM CLASS HELICAL STONE BASKETSTONE BASKETC.R. BARD, INC.FFLNA039595UNKK961248NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-12-3001. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE DOCTOR PLACED A STONE BASKET THEN WENT ALONG SIDE OF THE BASKET WITH A LASER FIBER AND BROKE A 5MM STONE IN THE PROXIMAL URETER INTO 3 PIECES. USING THE STONE BASKET, HE CAPTURED ALL 3 STONES INTO BASKET AT ONCE AND THEN WAS UNABLE TO CLOSE BASKET FOR REMOVAL. HE UNSCREWED HANDLE, REMOVED HANDLE AND SHEATH AND WENT BACK IN WITH A FLEXIBLE URETEROSCOPE AND LASER FIBER. HE THEN ATTEMPTED TO LASE THE STONES INSIDE THE BASKET AND THE SHAFT BROKE JUST BELOW THE BASKET. THE METAL WAS CHARRED, BLACKENED AND BENT AT THE BREAK SITE WHICH WAS OUTSIDE THE SCOPE OF THE LASER ENERGY. A PERCUTANEOUS PROCEDURE WAS PERFORMED SEVERAL DAYS LATER TO REMOVE THE BROKEN PORTION OF THE STONE BASKET. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT TOLERATED PROCEDURE WELL.