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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G21360
Device Problem Difficult to Remove (1528)
Patient Problem Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
Corrected from adverse event to adverse event and product problem. Additional information 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, "tulip, device is unable to be retrieved, bleeding. " cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Unknown if the reported device is unable to be retrieved and bleeding is directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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. 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
The event is currently under investigation. A supplemental report will be provided upon conclusion. (b)(4).
 
Event Description
It is alleged that [pt] received a gunther tulip filter on (b)(6) 2015. This additional information received on april 27, 2017 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the right femoral vein due to left common femoral vein deep vein thrombosis (dvt) and pulmonary embolism (pe). Plaintiff is alleging device is unable to be retrieved and bleeding. Additional information provided determined that this device was manufactured by cook inc.
 
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Brand NameGUNTHER TULIP JUGULAR & 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 Key6587053
MDR Text Key250780646
Report Number1820334-2017-01250
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberG21360
Device Catalogue NumberIGTCFS-65-UNI
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 Received09/05/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/16/2014
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: 05/24/2017 Patient Sequence Number: 1
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