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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34309
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2017
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, since the complaint was not returned and no imaging was provided. Given the limited information provided, it would be inappropriate to speculate at what may or may not have led to the reported deployment difficulties. It is noted that the filter was released in the correct position. 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. Cook will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(6). Catalog #: igtcfs-65-1-jug-celect-pt. Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: when the doctor was ready to deploy the filter, he pressed the red and blue buttons per ifu. When trying to remove the delivery system, the filter was still hooked to the delivery system. There was resistance. The doctor twisted the delivery system around until it became free from the filter. The filter deployed successfully in the correct position. Patient outcome: the patient did not require any additional procedures due to this occurrence. No adverse effects to the patient due to this occurrence.
 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN JUGULAR 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 Key6455740
MDR Text Key250016446
Report Number3002808486-2017-00868
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34309
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date03/15/2017
Device Age2 MO
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/12/2017
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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