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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); No Information (3190)
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 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. 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
Investigation - it is unknown if the reported claims of psychological issue(s) are directly related to the filter. We are unable to identify a corresponding failure mode at this point in time. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided. Cook will reopen its investigation if further information is received. The additional information received does not change the conclusion of the previously completed investigation.
 
Manufacturer Narrative
(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 02feb2018 as follows: pt allegedly received an implant on (b)(6) 2008 via the right femoral vein due to left leg deep vein thrombosis (dvt). Pt is alleging tilt, organ perforation ¿mesenteric, device is unable to be retrieved, embedment, post-implant dvt (left leg). Pt further alleges anxiety. Attempted retrieval (b)(6) 2009.
 
Manufacturer Narrative
(b)(4). 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) 2008. It is alleged that the patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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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 Key7134917
MDR Text Key258208287
Report Number1820334-2017-04653
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,Followup
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2018
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2017 Patient Sequence Number: 1
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