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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT FEMORAL & JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-UNI-CELECT
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog # igtcfs-65-uni-celect. Similar to device under 510(k) k073374. Summary of investigational findings: investigation is based on event description and returned product. Investigation of returned product confirms that two of the secondary filter legs are twisted around closest primary leg. After untwisting, the secondary legs are slightly asymmetric and one is slightly deform, but not bending outwards. No damages to introducer systems. Unable to determine exact reason for twisted legs and for reported secondary leg(s) bending outwards. If bending outwards it would be possible to collapse the secondary leg on a femoral loaded filter and advance it into the sheath. No reporting of attempts to reload filter to jugular introducer. Assuming a second introducer was used to place another filter afterwards. There is found no evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to complainant: during the procedure, the dr. Was unable to insert the filter through the sheath since 1x of the filter 'arms' would not bend into the sheath as it was continually bent outwards. Accordingly, the filter was placed aside and a new filter was opened and used without issue. Patient outcome: the patient did not require any additional procedures due to this occurrence. No adverse effects to the patient were reported due to this occurrence.
 
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Brand NameCOOK CELECT FEMORAL & JUGULAR 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 Key5902806
MDR Text Key52952465
Report Number3002808486-2016-00976
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-UNI-CELECT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/25/2016 Patient Sequence Number: 1
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