• 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 FEMORAL 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 FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34502
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). Manufacturer ref# (b)(4). (b)(4). Summary of investigational findings: complete device returned in original packaging. Femoral introducer returned inside blue sheath. The blue sheath was severely damaged in the proximal end as well as in the distal end. The filter was still loaded to the femoral introducer, but 5 secondary filter legs were damaged and bent upwards against the filter hook. These findings combined with imaging provided and the fact that "the filter was still attached by the primary struts and resheathed, pulled back into sheath" clearly indicate that attempts had been made to resheath the preexpanded filter, when attempting to optimize the filter placement after it deployed "improperly", ie after the secondary legs had expanded. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended during attempted filter placement. Cook medical will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(4). Catalog #: igtcfs-65-1-fem-celect-pt. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: first filters secondary struts appeared to deploy improperly. The filter was still attached by the primary struts and resheathed, pulled back into sheath and used a second filter. Patient outcome: the patient did not require any additional procedures due to this occurrence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOOK CELECT® PLATINUM NAVALIGN FEMORAL 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 Key6371142
MDR Text Key198308644
Report Number3002808486-2017-00685
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34502
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/22/2017
Device Age6 MO
Event Location No Information
Date Manufacturer Received02/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-