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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
Catalog Number IGTCFS-65-FEM
Device Problem Structural Problem (2506)
Patient Problems Myocardial Infarction (1969); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2020-00728. Occupation - (b)(6). 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 of this initial medwatch report. Blank fields on this form indicate the information is unknown or unavailable. Investigation: the following allegations have been investigated: vena cava perforation, heart attack, physical limitations. The reported allegations have been further investigated based on the information provided to date. The following allegations have been investigated: vena cava perforation, heart attack, 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. Unknown if the reported heart attack and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time 20 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. 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 an implant on (b)(6) 2010 via the common femoral vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe). Patient is alleging vena cava perforation. The patient further alleges a post-implant heart attack and physical limitations. Report from ct: "ivc filter in place with apex below the renal veins. There is likely penetration of the anterior wall of the ivc by one of the tines ventrally. ".

 
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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 Key10528825
MDR Text Key206789348
Report Number1820334-2020-01677
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 09/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/01/2013
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number2483286
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/31/2010
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: 09/14/2020 Patient Sequence Number: 1
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