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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Perforation of Vessels (2135); Injury (2348); Blood Loss (2597); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Corrected data based on new information received: adverse event to product malfunction; 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 06/02/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2014 due to deep vein thrombosis and pulmonary embolism. Plaintiff is alleging back and leg pain, and bleeding.
 
Manufacturer Narrative
Manufacturer reference # (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 ¿back and leg pain, bleeding". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Unknown if the reported back and leg pain, bleeding is directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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. 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, k090140, k112119, k121057 or k121629. Mfr 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) 2014 at (b)(6) medical center. " 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, k090140, k112119, k121057 or k121629. 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) 2014. " 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. Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Information regarding the event has not been provided. 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) 2014. " patient outcome; it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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Brand NameCOOK CELECT® PLATINUM 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
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key5801655
MDR Text Key192889402
Report Number3002808486-2016-00735
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
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 05/17/2019
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
Device Expiration Date03/10/2017
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device Lot NumberE3192043
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/12/2016
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
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: 07/18/2016 Patient Sequence Number: 1
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