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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-FEM-CELECT-PERM
Device Problems Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Thrombus (2101); Vascular System (Circulation), Impaired (2572); Blood Loss (2597); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). Manufacturer reference # (b)(4). Corrected data based on new information received: adverse event to product problem. Serious injury to malfunction. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "pulmonary embolism, difficult to retrieve, tilt, ivc thrombus due to filter, and bleeding". Cook will reopen its investigation if further information is received. Pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. With all filters, there is some risk of further pulmonary embolism. Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature. Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. 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.
 
Manufacturer Narrative
(b)(4). William cook (b)(4) (manufacturer) is submitting this report on behalf of (b)(4) (importer). (b)(4). Lot#: unknown as information was not provided catalog#: unknown but referred to as a cook celect filter expiration date: unknown as lot# is unknown name and address for importer site: (b)(4). Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140. (b)(4). It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a celect filter on (b)(6) 2009". Patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). 510(k) k073374. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 04/17/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2009 via the right femoral vein due to dvt. Plaintiff is alleging tilt, device is unable to be retrieved, bleeding, other: filter developed clot around it and a part of it broke off and resulted in the left pulmonary embolus, other: thrombus extending to the superior most tip of the ivc filter.
 
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Brand NameCOOK CELECT FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6455748
MDR Text Key203454269
Report Number3002808486-2017-00915
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-FEM-CELECT-PERM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date03/23/2017
Event Location No Information
Date Manufacturer Received07/11/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/16/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/04/2017 Patient Sequence Number: 1
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