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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Edema (1820); Thrombosis (2100); No Information (3190); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Blank fields on this form indicate the information is unknown or unavailable. Catalog #: unknown but referred to as a cook celect filter. (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
It is alleged that "[pt] received a celect filter on (b)(6) 2011". It is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
This additional information received on 01jun2018 as follows: pt allegedly received an implant on (b)(6) 2011 via inferior vena cava due to deep vein thrombosis, acute venous embolism, pulmonary embolus and thrombosis of unspecified deep vessels. Pt is alleging device unable to be retrieved, bleeding, life-long anticoagulant therapy, bilateral recurrent dvts, chronic occlusion of inferior vena cava , life-style debilitating leg edema. Pt further alleges post implant dvt, leg swelling, chronic pain.
 
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Brand NameCOOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key7524948
MDR Text Key108603238
Report Number3002808486-2018-00591
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other Caregivers
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/27/2013
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT
Device Lot NumberE2665129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/08/2018
Event Location No Information
Date Manufacturer Received06/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2010
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: 05/18/2018 Patient Sequence Number: 1
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