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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 Unexpected Therapeutic Results (1631)
Patient Problems Pulmonary Embolism (1498); Occlusion (1984); Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative

The previous mdr was submitted by wce under manufacturer report reference number 3002808486-2019-01777. Additional information provided determined that this device was manufactured by 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: investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines. This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters. Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism. Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines. This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters. Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis. Unknown if the reported pain, mental anguish, emotional distress, physical impairment, fear are directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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. The device is manufactured and inspected according to current controls. The following allegations have been investigated: pulmonary embolism, deep vein thrombus, inferior vena cava occlusion, pain, mental anguish, emotional distress, physical impairment, fear. 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 report will be submitted should additional information become available.

 
Event Description

Patient allegedly received an implant on (b)(6) 2011 due to deep vein thrombosis (dvt). Patient is alleging thrombosis. The patient further alleges physical pain, mental anguish, emotional distress, physical impairment and fear. Per a computerized tomography (ct) scan of the abdomen and pelvis dated (b)(6) 2017, ¿ivc filter with presumptive occlusion of the ivc below the level of the filter, with numerous superficial and deep pelvic collateral vessels. ¿.

 
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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 Key9799919
MDR Text Key194615452
Report Number1820334-2020-00562
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 03/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/27/2014
Device MODEL NumberG33016
Device Catalogue NumberIGTCFS-65-FEM
Device LOT Number2744066
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/27/2011
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: 03/06/2020 Patient Sequence Number: 1
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