• 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 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
 

COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-FEM
Device Problems Structural Problem (2506); Device Tipped Over (2589)
Patient Problems Chest Pain (1776); Dyspnea (1816); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative
Non-healthcare professional investigation the reported allegations have been further investigated based on the information provided to date. The following allegation has been investigated: vena cava perforation. Filter interacts with ivc wall, e. G. Penetration/perforation/embedment. This may be either symptomatic or asymptomatic. Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration. Catalog and lot # are unknown, however, the alleged tulip is manufactured and inspected according to specifications. 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. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. This report includes information known at this time. A follow-up medwatch report will be submitted if additional relevant information becomes available.
 
Event Description
The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2007 and underwent a computed tomography (ct) scan, approximately 10 years and 9 months later, which revealed that the patient's ivc filter had moved since its implantation as several struts were now perforating through the patient's ivc wall. Hospital and medical records have been requested, but not yet provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11618887
MDR Text Key251088716
Report Number1820334-2021-01075
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2010
Device Catalogue NumberIGTCFS-65-FEM
Device Lot Number1869416
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 Received08/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2007
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: 04/06/2021 Patient Sequence Number: 1
-
-