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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-TULIP
Device Problem Occlusion Within Device (1423)
Patient Problem Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Similar to device under 510(k): k090140. (b)(4). Summary of investigational findings: according to the description of event, a clot was "trapped in the filter causing issues with patient mobility and very swollen legs. " no image is provided to assist the investigation and patient's medical records are unknown at this time. Therefore, it would be inappropriate to speculate on what may or may not have led to the reported clot in the filter causing issues with patient mobility. Reference is made to ifu, potential adverse events: pulmonary embolism, filter embolization, vena cava occlusion or thrombosis. 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 medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: clot trapped in the filter causing issues with patient mobility and very swollen legs. Patient put on warfarin. Patient outcome: unknown as information was not provided.
 
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Brand NameGUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key6335130
MDR Text Key67538795
Report Number3002808486-2017-00369
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIGTCFS-65-2-UNI-TULIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2014
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/16/2017 Patient Sequence Number: 1
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