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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
Catalog Number IGTCFS-65-FEM
Device Problems Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Anxiety (2328); No Information (3190)
Event Type  malfunction  
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) 2009 via the femoral vein due to an amputated left lower extremity and prophylaxis to possible pulmonary embolism. Pt is alleging tilt, device unable to be retrieved. Pt further alleges anxiety.
 
Manufacturer Narrative
Investigation: investigation is reopened due to additional information provided. 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 -tilt, device unable to be retrieved, anxiety'. 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. 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. Unknown if the reported anxiety is directly related to the filter and unable to identify corresponding failure mode(s) at this time. No relevant notes on work order. No other complaints on lot. Product is manufactured and inspected according to specifications. 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, unavailable or unchanged. 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. 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
Patient code and device code: no information regarding the event has been provided. The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that plaintiff received a gunther tulip filter on (b)(6) 2009. 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 NameGUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7134906
MDR Text Key253236440
Report Number1820334-2017-04651
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 02/26/2018
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? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-FEM
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

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