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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-UNI-CELECT
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Pain (1994); Anxiety (2328); Injury (2348); Disability (2371)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Name and address for importer site:(b)(4). Corrected data based on new information received: product lot # e3007943 (corrected) the event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). 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 "the plaintiff alleges that the device is unable to be retrieved, pain, anxiety, disability, scarring and disfigurement¿. Cook will reopen its investigation if further information is received. Unknown if the reported ¿pain, anxiety, disability, scarring and disfigurement¿ is directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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. Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2013 at (b)(6) health center in (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). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 08/05/2016 as follows: the plaintiff allegedly received the device implant on (b)(6) 2013 due to dvt and immobility. The plaintiff alleges that the device is unable to be retrieved, pain, anxiety, disability, scarring and disfigurement.
 
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Brand NameCOOK CELECT NAVALIGN JUGULAR & 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 Key5778118
MDR Text Key130224422
Report Number3002808486-2016-00677
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,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/30/2016
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/14/2012
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: 07/08/2016 Patient Sequence Number: 1
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