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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 G33016
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Perforation of Vessels (2135); Disability (2371)
Event Type  Injury  
Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2019-00907. Additional information provided determined that this device was manufactured by cook inc. With the submission of this initial medwatch report, cook inc. Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # referenced in this initial medwatch report. Blank fields on this form indicate the information is unknown, unavailable, or unchanged. Occupation: non-healthcare professional (attorney). (b)(4). Investigation: the investigation was reopened due to additional information provided. The following allegations have been investigated: vena cava perforation, tilt, constant pain in groin area, itching/numbness on leg, anxiousness, and disability. The reported allegations have been further investigated based on the information provided to date. Vena cava wall penetration/perforation has been reported and may be either symptomatic or asymptomatic. Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation. Filter tilt has been reported. Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt. Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency. Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt. Unknown if the reported constant pain in groin area, itching/numbness on leg, anxiousness, and disability are directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. This report includes information known at this time. A follow-up medwatch report will be submitted if additional relevant information becomes available.

 
Event Description

Patient allegedly received an implant on (b)(6) 2012 via the right common femoral vein due to dvt (deep vein thrombosis). Patient is alleging tilt and penetration. The patient is further alleging "constant pain groin area, itching and numbness on leg. I want this removed. " and "i feel i am going out of my mind and very anxious. I snap easily since the implant. I am handicapped after the implant. " per report from ct (computed tomography) dated (b)(6) 2019, "there is an ivc filter. The upper aspect-apex of the inferior vena cava filter is tilted towards the right side and posteriorly, forming an angle with the vena cava of approximately 10. The apex of the inferior vena cava filter is approximately 2 cm below the bilateral renal veins. The apex of the inferior vena cava and the 4 limbs all project up to 3 mm beyond the wall of the inferior vena cava. There is no filter strut fracture or bending. There is no stenosis of the inferior vena cava. ".

 
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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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8917039
MDR Text Key158103121
Report Number1820334-2019-02069
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/01/2015
Device MODEL NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number3570472
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2012
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: 08/21/2019 Patient Sequence Number: 1
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