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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
Model Number N/A
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Perforation of Vessels (2135); Blood Loss (2597); No Information (3190)
Event Date 05/12/2016
Event Type  Injury  
Manufacturer Narrative
Investigation - evaluation: a review of documentation, review of complaint history, and specifications was conducted during the investigation. The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed. 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 'tulip, vena cava perforation, bleeding, device is unable to be retrieved". 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. Based on the provided information a definitive root cause cannot be established or reported at this time.
 
Manufacturer Narrative
The event is currently under investigation.
 
Event Description
It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2006 at (b)(6) medical center in (b)(6). ¿ it is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2006 at (b)(6). ¿ it is alleged that patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 01/28/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right common femoral vein due to blood clot. Plaintiff is alleging vena cava perforation, bleeding, device is unable to be retrieved. Plaintiff alleges attempted retrieval on (b)(6) 2016.
 
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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 Key6274029
MDR Text Key129804684
Report Number1820334-2017-00076
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,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 07/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
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 Received06/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/24/2017 Patient Sequence Number: 1
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