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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 Complete Blockage (1094); Insufficient Information (3190)
Patient Problems Atrial Fibrillation (1729); Occlusion (1984); Thrombosis (2100); 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 'ivc filter chronically thrombosed, ivc occluded, atrial fibrillation, abdominal pain'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature. Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic. Unknown if the reported abdominal pain is directly related to the filter and unable to identify a corresponding failure mode at this time. 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
(b)(4). The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that "[pt] received a cook gunther tulip on (b)(6) 2004. ¿ it is alleged that the patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
(b)(4). Corrected based on documentation provided by plaintiff's attorney. Selection corrected from no selection to product problem based on documentation provided by plaintiff's attorney. Selection corrected from no selection to serious injury based on documentation provided by plaintiff's attorney. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on (b)(6) 2017 as follows: plaintiff allegedly received an implant on (b)(6) 2004 via the right jugular vein due to a history of extensive pe, poor pulmonary reserve, and lower extremity dvt. Plaintiff is alleging that the ivc filter is chronically thrombosed, the ivc is occluded, atrial fibrillation, and abdominal pain. Records from implantation center do not provide any brand information (manufacturer, lot number, product code) to identify the ivc filter allegedly implanted.
 
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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
8128294891
MDR Report Key6378484
MDR Text Key110481652
Report Number1820334-2017-00486
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 08/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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?
Distributor Facility Aware Date03/01/2017
Event Location No Information
Date Manufacturer Received08/21/2017
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

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