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

MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER 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
 

COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number BNF-40-PB
Device Problem Insufficient Information (3190)
Patient Problems Thrombus (2101); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.
 
Manufacturer Narrative
William cook europe initially reported event under mfr report # 3002808486-2016-00742. New information was received identifying that the product was a cook inc. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
Patient was allegedly treated for blood clots and claims to have received a birds nest implant on (b)(6) 1999. Patient is alleging bleeding, clots in lungs and veins.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6477491
MDR Text Key109651069
Report Number1820334-2017-00788
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P850049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberBNF-40-PB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/09/2016
Event Location No Information
Date Manufacturer Received06/29/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/11/1999
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: 04/10/2017 Patient Sequence Number: 1
-
-