FDA.reportPublic FDA data

MAUDE MDR 1970119

MDR report key
1970119
Report number
1018233-2010-00165
Event key
0
Event type
3
Date of event
2010-12-14
Date received
2011-01-13
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
NYCOLE SAYER
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 TIGERTAIL URETERAL CATHETERC.R. BARD, INC.EYBNA139005RETB0812R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-01-1301. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE DOCTOR PLACED THE TIGERTAIL CATHETER THROUGH A STRICTURE AND DILATED IT WITH A BALLOON. WHEN THE PATIENT RETURNED FOR FOLLOW-UP KUB, THE TIGERTAIL TIP WAS FOUND IN THE URETER. THE PATIENT WILL REQUIRE AN ADDITIONAL URETHROSCOPY PROCEDURE TO REMOVE THE TIP. NO INJURY HAS BEEN REPORTED AT THIS TIME.

N

Patient 1

THE ORIGINAL SAMPLE WAS DISCARDED. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE DIRECTIONS FOR USE STATES IN THE CAUTION SECTION: "DO NOT WITHDRAW URETERAL CATHETER WHILE IT IS DEFLECTED IN ENDOSCOPE. AVOID SHARP BENDING. WHEN USING THE DEVICE WITHOUT THE STABILIZING SUPPORT OF A GUIDEWIRE, BE AWARE THAT A MALFUNCTION MAY OCCUR WHERE THE FLEXIBLE TIP MAY DETACH IF EXCESSIVE FORCE IS MADE IN CONTACT WITH THE WALLS OF THE BLADDER, URETER OR RENAL PELVIS. SHOULD THE FLEXIBLE PORTION OF THE CATHETER BECOMES DETACHED, RETRIEVE WITH AN ENDOUROLOGY GRASPING DEVICE." (B)(4).