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U.S. Department of Health and Human Services

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

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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG
Device Problems Structural Problem (2506); Device Tipped Over (2589)
Patient Problems Perforation of Vessels (2135); Bowel Perforation (2668)
Event Type  Injury  
Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2020-01165. Reporter occupation: non-healthcare professional. 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. Investigation: investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. The following allegations have been investigated: vena cava/organ perforation, tilt, physical limitations. Filter interacts with ivc wall, e. G. Penetration/perforation/embedment. This 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, vena cava penetration. 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 physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time. (b)(4) devices in lot. No relevant notes on work order. The 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 become available.

 
Event Description

Patient allegedly received a cook gunther tulip filter on (b)(6) 2012 via the right internal jugular vein due to deep vein thrombosis (dvt). Patient is alleging vena cava and organ perforation, as well as tilt. The patient further alleges physical limitations. Report from ct (computed tomography): "positive for caval perforation. Superior extent of ivc filter l 1-l2 disc space. Inferior extent mid l3 vertebral body. A total of 4 prongs have perforated through ivc series 5 image 37. Maximum distance prongs perforated through ivc 4. 67 mm series 5 image 37. Coronal images 2. 53 degree tilt left to right series 6 image 86. Sagittal images 0. 96 degree tilt posterior to anterior series 7 image 110. Diameter of ivc directly above filter 24. 56 mm x 18. 38 mm series 5 image 26. Attention: a prong has perforated the duodenum best appreciated on series 5 image 37. " retrieval report (successful): "the inferior venacavogram shows an intact infrarenal ivc filter, with no evidence of thrombus within the cook gunther tulip filter or cava. There is no significant filter tilt. There is caval penetration and several filter struts. 2. Follow-up cavogram revealed satisfactory result with no retained filter fragments and good flow in the ivc. No extravasation. No thrombus. ".

 
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Brand NameGUNTHER TULIP JUGULAR 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 Key11400166
MDR Text Key234411034
Report Number1820334-2021-00867
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/01/2013
Device Catalogue NumberIGTCFS-65-JUG
Device LOT Number2576806
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/24/2010
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: 03/02/2021 Patient Sequence Number: 1
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