MAUDE MDR 682318

MDR report key: 682318
Report number: 1018233-2006-00030
Event key: 0
Event type: 3
Date received: 2006-03-03
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 ASS 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
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	BARD TIGERTAIL POLYURETHANE URETERAL CATHETER	URETERAL CATHETER	C.R. BARD, INC.	EYB	NA	139005	REPL0274			N	Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2006-03-03	0	1. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE TIP OF THE URETERAL CATHERER BROKE OFF AND REMAINED INSIDE THE UPPER POLE OF THE LEFT RENAL PELVIS. THE PATIENT WAS INITIALLY DIAGNOSED AS HAVING A SMALL STONE IN THE URETER. WHEN THE DOCTOR ATTEMPTED TO PLACE A GUIDEWIRE, HE ENCOUNTERED DIFFICULTY. AN 8 FRENCH URETERAL CATHETER WAS THEN INTRODUCED AS A SHEATH TO STABILIZE THE GUIDEWIRE AND FACILITATE PASSAGE. THIS WAS SUCCESSFUL AND A RETROGRADE PLYOGRAM WAS PERFORMED. UPON REMOVAL OF THE URETERAL CATHETER, THE DOCTOR NOTED THE TIP OF THE CATHETER WAS MISSING. THE DOCTOR DILATED THE URETER USING A BALLOON DILATION CATHETER AND FLUSHED OUT THE STONE. UNDER FLUOROSCOPY, HE WAS ABLE TO VISUALIZE THE TIP OF THE CATHETER FLOATING IN THE UPPER POLE OF THE LEFT RENAL PELVIS. THE TIP WILL BE REMOVED AT ANOTHER FACILITY AS TREATING PHYSICIAN DID NOT BELIEVE HE COULD REACH THE TIP USING THE EQUIPMENT HE HAD AVAILABLE. THE PATIENT WAS RELEASED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
03600040963869	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040963920	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040964019	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040964071	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040964163	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040964224	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040964286	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040964347	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040964408	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040964644	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040965870	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040965931	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040965993	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966051	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966112	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966204	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966297	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966389	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966471	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966532	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966594	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966655	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966716	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966778	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966839	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966891	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040966983	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040967041	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040967133	Coloplast	Coloplast A/S	EYB	2026-01-30
03600040967195	Coloplast	Coloplast A/S	EYB	2026-01-30

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K192183	EYB	RocaTub Ureteral Catheter	Promepal Sam	2020-04-23
510(k)	K191187	EYB	Dornier MINNOW Ureteral Catheter	Dornier Medtech America, Inc.	2019-09-18
510(k)	K183323	EYB	UPJ Occlusion Balloon Catheter	Cook Incorporated	2019-08-05
510(k)	K182695	EYB	Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter	Cook Incorporated	2019-06-17
510(k)	K182122	EYB	Ureteric Catheters	Coloplast Corp.	2018-10-04

MAUDE MDR 682318

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Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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