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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

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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Chest Pain (1776); Thrombus (2101); No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  malfunction  
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 'unable to retrieve, thrombus in filter, chest pain'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. 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 chest 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
Blank fields on this form indicate the information is unknown or unavailable. (b)(4). The event is currently under investigation.
 
Event Description
It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2007 at (b)(6) hospital (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 received 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) 2007 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). Blank fields on this form indicate the information is unknown or unavailable or unchanged. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 04/26/2017 and is as follows: patient alleges that filter was placed on (b)(6) 2007 via the femoral route for pulmonary embolism. Patient alleges that outcomes attributed to device include: the device is unable to be retrieved and thrombus in the filter. Patient also alleges complaints of intermittent chest pain. Patient alleges no attempts to retrieve device.
 
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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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6148779
MDR Text Key250913459
Report Number1820334-2016-01403
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 Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 09/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberIGTCFS-65-FEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date11/10/2016
Event Location No Information
Date Manufacturer Received08/24/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/06/2007
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: 12/06/2016 Patient Sequence Number: 1
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