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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
Model Number G34502
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: investigation is solely based on description of event, no product was returned and no imaging was provided to assist the investigation. Given the limited information provided, it would be inappropriate to speculate at what may or may not have led to the reported filter leg not expanding after deployment. 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-fem-celect-pt. (b)(4). Iinvestigation is still in progress.
 
Event Description
Description of event according to initial reporter: when they deployed the filter, the filter detached but the legs did not open up. They were able to use a wire guide to get the legs to open up. The legs opened up and the filter was deployed in the correct place. Patient outcome: the patient did not require any additional procedures due to this occurrence.
 
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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 Key6371131
MDR Text Key248324598
Report Number3002808486-2017-00684
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34502
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 Date02/16/2017
Device Age2 MO
Event Location No Information
Date Manufacturer Received02/17/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/05/2016
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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