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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 Dyspnea (1816); Thrombosis (2100); Perforation of Vessels (2135); Anxiety (2328)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Investigation: 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. A total of 20 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. 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. A follow-up medwatch report will be submitted if additional relevant information become available.

 
Event Description

Report from computerized tomography (ct): "ivc filter with lower struts outside the caval wall, no clinical significance. ".

 
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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 Key9916007
MDR Text Key196573699
Report Number1820334-2020-00733
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,Followup
Report Date 05/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/01/2015
Device MODEL NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number3219618
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 Received04/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2012
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: 04/02/2020 Patient Sequence Number: 1
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