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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 Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Atrial Fibrillation (1729); Pain (1994); Thrombus (2101); No Information (3190)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog# is unknown but referred to as cook celect filter. Name and address for importer site: (b)(4). 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 of event according to short form complaint filed: it is alleged that "[pt] received a cook celect platinum filter on (b)(6) 2015". 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

Exemption number e2016032. (b)(4). Pma/510(k) k121629. The event is currently under investigation. A supplemental report will be submitted upon completion.

 
Event Description

This additional information received on 21dec2017 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the left common femoral vein the due to deep vein thrombosis and intracranial hemorrhage. Pt alleges tilt, device is unable to be retrieved and deep vein thrombosis. The pt further alleges pain, anxiety, bleeding from incision, suspect atrial fibrillation and an unsuccessful attempted filter retrieval on (b)(6) 2015. The filter was explanted, intact, during a second attempted retrieval on (b)(6) 2015.

 
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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 Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7056758
MDR Text Key92833526
Report Number3002808486-2017-02267
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 01/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date11/02/2017
Device Age5 mo
Event Location No Information
Date Manufacturer Received01/05/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/10/2015
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: 11/23/2017 Patient Sequence Number: 1
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