• 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 NAVALIGN COOK CELECT JUGULAR 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 NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-JUG-CELECT
Device Problems Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Perforation of Vessels (2135); Palpitations (2467); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog# is unknown but referred to as cook celect filter. Occupation: non-healthcare professional. It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.

 
Event Description

It is alleged that "[pt] received a cook celect filter on (b)(6) 2011. It is alleged that the [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided. ".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key10281679
MDR Text Key199059051
Report Number3002808486-2020-00717
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/05/2013
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT
Device LOT NumberE2630101
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 Received08/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/05/2010
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: 07/16/2020 Patient Sequence Number: 1
-
-