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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 Problems Complete Blockage (1094); Device Operational Issue (2914)
Patient Problems Pulmonary Embolism (1498); Chest Pain (1776)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Investigation - 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 ¿failed to prevent pe". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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 product was not manufactured to specification.

 
Event Description

Plaintiff allegedly received an implant on (b)(6) 2010 via the left femoral vein due to dvt and pe despite adequate anticoagulative therapy. Per medical records, patient is experiencing a small volume of recurrent pe despite ivc filter.

 
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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 Key6901102
MDR Text Key87651780
Report Number1820334-2017-03451
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
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 10/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2017
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 Received09/28/2017
Was Device Evaluated By Manufacturer? No Answer Provided
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: 09/28/2017 Patient Sequence Number: 1
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