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U.S. Department of Health and Human Services

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

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COOK INC GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-UNI
Device Problem Occlusion Within Device (1423)
Patient Problems Pain (1994); Thrombosis (2100)
Event Type  Malfunction  
Manufacturer Narrative

William cook europe initially reported event under manufacturer report #: 3002808486-2018-00483. New information was received identifying that the product was a cook inc. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

 
Event Description

This additional information received on 05/01/2018 as follows: pt allegedly received an implant on (b)(6) 2018 via the right internal jugular vein due to chronic right leg deep vein thrombosis, unable to be anticoagulated secondary to brain hemorrhage. Pt is alleging occlusion and recurrent deep vein thrombosis. Pt. Further alleges general pain, mental anguish and deep vein thrombosis after implant.

 
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Brand NameGUNTHER TULIP JUGULAR & 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 Key7554472
MDR Text Key109764047
Report Number1820334-2018-01640
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,Followup
Report Date 05/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/01/2014
Device Catalogue NumberIGTCFS-65-UNI
Device LOT Number3693054
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 Received05/13/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/25/2012
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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