MAUDE MDR 9391853

MDR report key: 9391853
Report number: 1016427-2019-03612
Event key: 0
Event type: 3
Date of event: 2019-04-25
Date received: 2019-11-29
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: MRS. KARLA CASTRO
Address: 14201 NW 60TH AVE MIAMI LAKES FL 33014 US
Phone: 786-786-7863
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	466FXXXX	FILTER, INTRAVASCULAR, CARDIOVASCULAR	CORDIS CASHEL	DTK	466FXXXX	466FXXXX	UNK				N	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-29	0	1. L

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00886333217519	Option Elite Retrievable Vena Cava Filter	ARGON MEDICAL DEVICES, INC.	DTK	2019-07-26
03760017680004	ALN Optional Vena Cava Filter - Femoral Approach	A.L.N.	DTK	2018-10-26
03760017680011	ALN Optional Vena Cava Filter - Jugular Approach	A.L.N.	DTK	2018-10-26
03760017680028	ALN Optional Vena Cava Filter - Brachial Approach	A.L.N.	DTK	2018-10-26
03760017680042	ALN Optional Vena Cava Filter - Femoral Approach with Hook	A.L.N.	DTK	2018-10-26
03760017680059	ALN Optional Vena Cava Filter - Jugular Approach with Hook	A.L.N.	DTK	2018-10-26
03760017680066	ALN Optional Vena Cava Filter - Brachial Approach with Hook	A.L.N.	DTK	2018-10-26
03760017680103	ALN Straight RS	A.L.N.	DTK	2018-10-26
03760017680110	ALN Pre-Curved RS	A.L.N.	DTK	2018-10-26
03760017680127	ALN 2in1	A.L.N.	DTK	2018-10-26
05391529380069	Sentry IVC Filter	NOVATE MEDICAL LIMITED	DTK	2018-09-27
05391529380076	Sentry IVC Filter	NOVATE MEDICAL LIMITED	DTK	2018-09-27
20705032009369	OPTEASE	CORDIS CORPORATION	DTK	2017-09-18
04046964332333	VENA TECH	B. BRAUN MEDICAL INC.	DTK	2017-01-18
00886333222346	Option Elite Retrievable Vena Cava Filter	ARGON MEDICAL DEVICES, INC.	DTK	2016-09-23
00886333217151	Option Elite Retrievable Vena Cava Filter System	ARGON MEDICAL DEVICES, INC.	DTK	2016-09-21
04027478130318	VENA TECH™	B BRAUN INTERVENTIONAL SYSTEMS, INC	DTK	2016-08-09
04027478130752	VENA TECH	B BRAUN INTERVENTIONAL SYSTEMS, INC	DTK	2016-03-17
08714729050650	Entry Kit	BOSTON SCIENTIFIC CORPORATION	DTK	2016-01-29
10827002355801	Cook Celect	William Cook Europe ApS	DTK	2015-12-07
00857141005001	OptionELITE Vena Cava Filter	Rex Medical LLP	DTK	2015-12-07
00857141005018	OptionELITE Vena Cava Filter, 100cm	Rex Medical LLP	DTK	2015-12-07
10827002037660	Gunther Tulip	William Cook Europe ApS	DTK	2015-10-24
10827002037677	Cook Celect	William Cook Europe ApS	DTK	2015-10-24
10827002213606	Gunther Tulip	COOK INCORPORATED	DTK	2015-10-24
10827002330167	Gunther Tulip	COOK INCORPORATED	DTK	2015-10-24
10827002330174	Gunther Tulip	COOK INCORPORATED	DTK	2015-10-24
10827002355900	Cook Celect	William Cook Europe ApS	DTK	2015-10-24
10827002529097	Cook Celect	William Cook Europe ApS	DTK	2015-10-24
10827002529141	Cook Celect	William Cook Europe ApS	DTK	2015-10-24

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K242612	DTK	Option ELITE Vena Cava Filter System (352506070E 352506100E)	Argon Medical Devices, Inc.	2024-09-10
510(k)	K240578	DTK	VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System	B.Braun Medical, Inc.	2024-07-31
510(k)	K241507	DTK	ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)	Aln S.A.R.L.	2024-06-26
510(k)	K240257	DTK	Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit	Bd	2024-02-29
510(k)	K233680	DTK	Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter	William Cook Europe Aps	2024-01-18
PMA	P850049S009	DTK	BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	2006-02-03
PMA	P850049S008	DTK	GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER	Cook, Inc.	2002-02-13
PMA	P850049S007	DTK	GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1999-09-14
PMA	P850049S006	DTK	GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1998-12-21
PMA	P850049S005	DTK	COOK BIRD'S NEST VENA CAVA FILTER	Cook, Inc.	1996-09-17

MAUDE MDR 9391853

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

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