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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Atherosclerosis (1728); Myocardial Infarction (1969); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

The previous mdr was submitted by (former manufacturer) under manufacturer report reference# 3002808486-2019-00165. Additional information provided determined that this device was manufactured by cook inc. With the submission of this initial report, cook inc. Informs that all future submissions regarding this complaint will be handled under this manufacturer report reference#. Additional information: occupation: non-healthcare professional. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

 
Event Description

Patient allegedly received an implant on (b)(6) 2010 via the jugular vein due to intracranial hemorrhage and subsequently developed acute deep vein thrombosis (dvt). Patient alleges tilt, vena cava perforation, left lateral strut extending 5mm abutting right iliac artery, chest pain, abnormal ecgs, st-elevation myocardial infarction (stemi) requiring stent placement, moderate diffuse atherosclerotic disease of the tibial vessels, leg swelling/pain, leg discoloration. Patient further alleges to have experienced, "my left leg and ankle are severely swollen. ".

 
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Brand NameGUNTHER TULIP JUGULAR 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 Key8427761
MDR Text Key139044211
Report Number1820334-2019-00643
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/01/2013
Device Catalogue NumberIGTCFS-65-JUG
Device LOT Number2481181
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 Received06/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/31/2010
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: 03/18/2019 Patient Sequence Number: 1
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