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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34505
Device Problems Difficult or Delayed Positioning (1157); Material Distortion (2977)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/19/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: investigation is based on description of event and the filter returned. Two secondary legs are crossed and one secondary leg and one primary leg are crossed. Leg width greater than the specification states, however this is assumed to be related to user handling, since wce has 100% control of each filter. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(4). Catalog # igtcfs-65-1-uni-celect-pt. (b)(4). Similar to device under 510(k) k121629. Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: "they attempted to deploy the filter but the legs were crossed. Removed the filter and placed another to complete the procedure. " patient outcome: no adverse effects on the patient due to this occurrence.
 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET 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 Key6568443
MDR Text Key249088505
Report Number3002808486-2017-01079
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34505
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/25/2017
Device Age3 MO
Event Location No Information
Date Manufacturer Received04/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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