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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 Structural Problem (2506)
Patient Problems Perforation of Vessels (2135); Anxiety (2328)
Event Type  Injury  
Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2021-01214. Additional information provided determined that this device was manufactured by cook inc (cinc). With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in this initial medwatch report. Occupation - non-healthcare professional. Investigation: the reported allegations have been further investigated based on the information provided to date. The following allegations have been investigated: vena cava perforation, anxiety, worry, fear, 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 anxiety, worry, fear, 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. 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 tulip implant on (b)(6) 2011 via the left common femoral vein due to deep vein thrombosis (dvt). Patient is alleging vena cava perforation. The patient further alleges anxiety, worry, fear, and physical limitations.

 
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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 Key12387770
MDR Text Key268806748
Report Number1820334-2021-02081
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,OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/01/2014
Device MODEL NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number2733360
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2011
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: 08/30/2021 Patient Sequence Number: 1
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