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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); Appropriate Term/Code Not Available (3191)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Chest Pain (1776); Dyspnea (1816); Injury (2348); Blood Loss (2597)
Event Date 06/01/2014
Event Type  malfunction  
Manufacturer Narrative
Manufacturer ref# (b)(4). Exemption number e2016032. (b)(4). 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 "plaintiff is alleging device unable to be retrieved, embedded, chest pain, shortness of breath, nausea, anxiety, attempted retrieval on 06/01/2014¿. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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. 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). Lot #: unknown as information was not provided. Catalog #: unknown but referred to as a cook celect filter. Expiration date: unknown as lot# is unknown. Since catalog # is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. Mfr date: unknown as lot# is unknown. Investigation is still in progress.
 
Event Description
Description according to short form complaint: it is alleged that "[pt] received a cook celect filter on (b)(6) 2013 at the (b)(6) university of (b)(6). " 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). Catalog: igtcfs-65-1-fem-celect. Investigation is still in progress.
 
Event Description
Description according to short form complaint: it is alleged that "[pt] received a cook celect filter (b)(6) 2013 at (b)(6)". 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) corrected data based on new information received: adverse event to product problem, serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 04/11/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2013 via the left common femoral vein due to mcv with liver lacerations. Plaintiff is alleging device unable to be retrieved, embedded, chest pain, shortness of breath, nausea, anxiety. Plaintiff alleges attempted retrieval on (b)(6) 2014.
 
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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
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
dk-4632 bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
dk-4632 bjaeverskov, IN 4632
DA   4632
8004574500
MDR Report Key5459498
MDR Text Key196699711
Report Number3002808486-2016-00062
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 other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/03/2015
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT
Device Lot NumberE2987458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/03/2016
Device Age19 MO
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/03/2012
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: 02/25/2016 Patient Sequence Number: 1
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