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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 Problems Complete Blockage (1094); Difficult to Remove (1528)
Patient Problems Pain (1994); Thrombosis (2100)
Event Type  Malfunction  
Manufacturer Narrative

William cook europe initially reported event under manufacturer report # 3002808486-2017-00651. New information was received identifying that the product was a cook inc. The related event for this plaintiff is mfr# 1820334-2017-01790. The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

Plaintiff allegedly received an infrarenal implant on (b)(6) 2010 due to pulmonary embolism. Plaintiff is alleging clotted infrarenal filter, pain in right side of torso and unable to be retrieved.

 
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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
8128294891
MDR Report Key6715144
MDR Text Key80128907
Report Number1820334-2017-01789
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 08/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG33016
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 Received08/21/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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