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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 Filtration Problem (2941)
Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Dyspnea (1816)
Event Type  Injury  
Manufacturer Narrative

William cook europe initially reported event under mfr report # 3002808486-2017-00174. New information was received identifying that the product was a cook inc. Manufactured device. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

Plaintiff allegedly received an implant on (b)(6) 2009 via the common femoral vein due to dvt and spine surgery. Plaintiff is alleging chest pain, shortness of breath, pe despite filter in place, systemic hypertension.

 
Manufacturer Narrative

Additional information: it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "pulmonary embolism, chest pain, shortness of breath, and systemic hypertension". Cook will reopen its investigation if further information is received. Pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. With all filters, there is some risk of further pulmonary embolism. 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.

 
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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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6563116
MDR Text Key75024377
Report Number1820334-2017-01032
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 ATTORNEY
Type of Report Initial,Followup
Report Date 08/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-FEM
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 Received07/23/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/18/2009
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: 05/12/2017 Patient Sequence Number: 1
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