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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
Model Number G33017
Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problems Fatigue (1849); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2020-00240. Occupation: non-healthcare professional. (b)(4). Investigation: the following allegations have been investigated: vena cava (vc) perforation, migration and limited physical activity. Investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. 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 or filter fragment migration and (or) embolization (e. G. , movement to the heart or lungs) has been reported. Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic. Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures. Unknown if the reported limited physical activity is directly related to the filter and unable to identify a corresponding failure mode at this point in time. A total of (b)(4) devices were manufactured in the reported lot. To date, no other complaints have been reported against the lot. The associated work order was reviewed. No related/relevant notes were documented. The device is manufactured and inspected according to current controls 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) 2014 via the right internal jugular vein due to post pulmonary embolism (pe). Patient is alleging vena cava perforation and migration. Patient notes and additionally alleges limits to physical activity. On (b)(6) 2018, per a report from computed tomography (ct); ¿impression: 3. Ivc filter within the aorta. It is not tilted or deviated. There is evidence for four distal prongs all of which appear to be projecting outside of the lumen of the ivc, the posterior left prongs is abutting the right lateral wall of the aorta. ¿.

 
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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 Key9896875
MDR Text Key196571756
Report Number1820334-2020-00704
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/01/2017
Device MODEL NumberG33017
Device Catalogue NumberIGTCFS-65-JUG
Device LOT Number4984278
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 Received03/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2014
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: 03/30/2020 Patient Sequence Number: 1
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