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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); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Internal Organ Perforation (1987); Perforation (2001); Thrombus (2101); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 or k073374. Mfr date unknown as lot # is unknown. 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) 2008. " 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 #: 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 or k073374. Mfr date unknown as lot# is unknown. 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 cook celect filter on (b)(6) 2008. " 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 02/14/2017 as follows: patient alleges filter placed due to history of dvt and scheduled knee surgery. Patient alleges the following outcomes as being attributed to the device: migration, vena cava perforation, device unable to be retrieved, organ perforation (duodenum), clot/thrombus, prong extended to l3 vert, aorta wall penetration or abutment.
 
Manufacturer Narrative
(b)(4). Evaluation: according to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu. It has not been possible to fully investigate or evaluate this 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.
 
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Brand NameCOOK CELECT FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key6192237
MDR Text Key62908825
Report Number3002808486-2016-01509
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,Followup
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Date12/08/2016
Event Location No Information
Date Manufacturer Received03/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/21/2016 Patient Sequence Number: 1
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