• 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 UNKNOWN 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 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Investigation- it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "gunther tulip filter implanted. " cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Product is manufactured and inspected according to manufacturing instructions and quality control instructions. 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
Additional information: investigation - filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. Vena cava wall perforation is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter. There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae. E. G. Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae. In contrast, perforation of adjacent organs is reported with clinical sequelae. Unknown if the reported anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time. Rpn and lot# are unknown, but the filter tulip is manufactured and inspected according to specification. 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
Corrected data: adverse event to adverse event and product problem. Outcomes attributed to adverse event: other to life-threatening. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
This additional information received on 31 jan 2018 as follows: ¿[pt] allegedly received an implant on (b)(6) 2006 via the right common femoral vein due to broken right femur. [pt] is alleging tilt, vena cava perforation, small bowel perforation, vertebral body perforation. [pt] further alleges anxiety. There are no retrieval attempts. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that the plaintiff received a gunther filter on (b)(6) 2006. It is alleged that the plaintiff 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 NameUNKNOWN
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 Key7125124
MDR Text Key258153260
Report Number1820334-2017-04448
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
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 Received03/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2017 Patient Sequence Number: 1
-
-