• 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 GUNTHER TULIP 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
 

COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG
Device Problems Difficult to Remove (1528); Unintended Movement (3026)
Patient Problems Pain (1994); Cramp(s) (2193)
Event Type  malfunction  
Manufacturer Narrative
William cook europe initially reported event under mfr report # 3002808486-2016-01389. New information was received identifying that the product was a cook inc. Manufactured device. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
Plaintiff allegedly received an implant on (b)(6) 2011 via the right internal jugular vein due to pulmonary embolism and left lower extremity dvt. Plaintiff is alleging tilt, device unable to be retrieved, cramping, pain.
 
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. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu. It has not been possible to fully investigate or evaluate this event based on the limited information provided to date.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGUNTHER TULIP JUGULAR VENA CAVA FILTER SET
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 Key6518088
MDR Text Key73612766
Report Number1820334-2017-00851
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072240
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 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-JUG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date11/07/2016
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-