• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-CELECT-PT
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/03/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: investigation is based on event description only. No imaging was provided and the product was not returned. Therefore, it would be inappropriate to speculate at what may or may not have led to the difficulties encountered when attempting to release the filter from the jugular introducer. However, reference is made to the ifu, warning that excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated. It is noted that the filter placement was accurate and that the patient experienced no adverse effects. 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-65-2-uni-celect-pt. (b)(4). Similar to device under 510(k) k121629. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: the ivc filter insertion case from the jugular access proceeded as normal to a situation whereupon the ivc filter was positioned in the ivc and ready to be released. The red safety button on the jugular deployment system was pressed before the blue 'release' button was released. Upon this release the ivc filter was partially seen to be released, and the blue 'release' button on the deployment system was released. The deployment system was then moved in order to be removed from the patient. However, as the deployment system was being retracted it was noticed that the ivc filter began to move - it seemed the deployment system was still attached to a part of the ivc filter. Gradual movement (up and down) was then required for a short period of time until it was presumed (visually and physically) that the deployment system was completely detached from the ivc filter. The deployment system was then retracted out of the sheath and a run was then completed. The ivc filter placement was still accurate and there was no observable trauma to the patient. The case was then completed to a successful conclusion. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET 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 Key6826289
MDR Text Key250982629
Report Number3002808486-2017-01670
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 foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT-PT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/07/2017
Device Age3 MO
Event Location No Information
Date Manufacturer Received11/23/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-