MAUDE MDR 9907376

MDR report key: 9907376
Report number: 1820334-2020-00723
Event key: 0
Event type: 3
Date received: 2020-03-31
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: MR. LARRY POOL
Address: 750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone: 812-812-8123
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	UNKNOWN	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	COOK INC	DTK		UNKNOWN	UNKNOWN				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-03-31	0	1. O

Event Narratives#

N

Patient 1

OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION: IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION AND/OR NO DEVICE FAILURE PROVIDED TO DATE. CATALOG NUMBER AND LOT NUMBER ARE UNKNOWN, HOWEVER, THE ALLEGED TULIP IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

D

Patient 1

IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP ON (B)(6) 2002. IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

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 9907376

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

N

D

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