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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-CELECT
Device Problems Bent (1059); Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Code Available (3191)
Event Date 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: the celect filter, the blue sheath, and the jugular introducer were returned. The filter was correctly shaped and without damages. On the sheath a penetration was noted approx. 33cm from the fitting, an incipient penetration approx. 35. 5cm from the fitting, and a severe penetration from 41. 5 to 42. 5cm from the fitting. The exact reason for these penetrations cannot be determined, but since reported that "the filter was introduced then but trapped when passing through the jugular vein" and "then the filter and sheath were moved back and forth together, trying to make the sheath get through the bending position of the vein", it is suggested that the sheath was not in correct position prior to advancing the jugular introducer and the filter. According to ifu the sheath position must be verified by diagnostic imaging and when correct position is established, the dilator must be removed and the introducer can be advanced. Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended. Cook medical will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(4). Catalog #: igtcfs-65-2-uni-celect, name and address for importer site: (b)(4). Similar to device under k090140. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: this patient, a (b)(6) pregnant woman, is severely obese. The point of the internal jugular vein puncture was elevated about 1cm because of the confined space. The vessel was smoothly dilated with an expansion tube and the deep vein thrombosis involving the opening of inferior vena cava looked normal under angiography. The filter was introduced then but trapped when passing through the jugular vein. After analysis, the reason was that the jugular vein was too short and steeply angled. Then the filter and sheath were moved back and forth together, trying to make the sheath get through the bending position of the vein, but failed. After several attempts, the sheath was ruptured and then withdrawn together with the filter. The filter was in good shape. After that, a new 8f sheath was used to strengthen the supporting force of the vessel but still couldn¿t pass through the bending position. Then the sheath and the filter were withdrawn together. The filter was bended then and could no longer be used. After talking to the patient, she agreed to implant a new filter through the right femoral vein, which succeeded eventually. The thrombosis was aspirated by long sheath. The patient showed no adverse reaction. Patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. ".
 
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Brand NameCOOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
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 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key6816257
MDR Text Key250695564
Report Number3002808486-2017-01663
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/01/2017
Device Age7 MO
Event Location No Information
Date Manufacturer Received08/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2016
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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