FDA.reportPublic FDA data

MAUDE MDR 744108

MDR report key
744108
Report number
1018233-2005-00045
Event key
0
Event type
3
Date received
2005-07-01
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 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 TIGERTAIL POLYURETHANE URETERAL CATHETERURETERAL CATHETERC.R. BARD, INC.EYBNA13900522KO3116NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-07-0101. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT AFTER INSERTING A RIGID SCOPE, A URETERAL CATHETER WAS PASSED OVER THE GUIDEWIRE, INTO THE KIDNEY. THE DOCTOR WAS ABLE TO VISUALIZE THE TIP OF THE CATHETER DISLOCATE AND FLOAT INTO THE KIDNEY. THE DOCTOR WAS ABLE TO RETRIEVE THE CATHETER TIP DURING THE INITIAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

N

Patient 1

THE ACTUAL SAMPLE AND EIGHT LOT SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE ACTUAL SAMPLE VERIFIED THE TIP OF THE CATHETER HAD DETACHED FROM THE SHAFT. NO OBVIOUS CAUSE OF THE DETACHMENT WAS OBSERVED. ALL RETURNED LOT SAMPLES WERE FLEXED OVER A PIGTAIL SHAPED WIRE AND THEN PULL-TESTED. ALL CATHETERS MET THE SPECIFICATION REQUIREMENTS FOR TENSILE VALUES. A REVIEW OF THE DEVICE HISTORY RECORDS THAT WERE INCLUDED IN THE LOT OF FINISHED PRODUCT SHOWED THAT ALL CATHETERS MET SPECIFICATION BEFORE SHIPPING THE PRODUCT. A SAMPLE FROM EACH LOT IS PULL TESTED AND ANOTHER SAMPLE IS TAKEN AND PULL TESTED EVERY 20TH PIECE DURING MANUFACTURING. THERE WERE NO FAILURES RECORDED FOR TENSILE VALUES BEING BELOW THE SPECIFIED REQUIREMENTS. NO CONCLUSION COULD BE REACHED ABOUT THE FAILURE IN THE FIELD AS TO ROOT CAUSE.