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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 Problem Insufficient Information (3190)
Patient Problems Pain (1994); Cramp(s) (2193); Injury (2348); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but refered 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 or k090140.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) 2010 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).Catalog #: unknown but refered 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 or k090140.Unknown as lot # is unknown.It has not been possible to investigate this event based on the limited information, and we are closing the report until further information is received.If additional information is received, the report will be re-opened for further investigation.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2010." 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 refered 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 or k090140.Mfr date unknown as lot # is unknown.It has not been possible to investigate this event based on the limited information, and we are closing the report until further information is received.If additional information is received, the report will be re-opened for further investigation.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2010." 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).Name and address for importer site: (b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 03/13/2017 as follows: the patient allegedly received the device implant via right common femoral vein on (b)(6) 2010 as prophylaxis for pulmonary embolus and dvt after car accident causing pelvic fracture and intracerebral injury.The patient is alleging pain, cramping, and that she can feel device moving.
 
Manufacturer Narrative
(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 "pain, cramping, and that she can feel device moving".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 ref# (b)(4).
 
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Brand Name
COOK CELECT FEMORAL VENA CAVA FILTER SET
Type of Device
DTK 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 Key5801607
MDR Text Key49753305
Report Number3002808486-2016-00744
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,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-FEM-CELECT-PERM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date07/12/2016
Date Manufacturer Received06/16/2017
Date Device Manufactured03/01/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Weight50
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