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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 Difficult to Remove (1528); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Internal Organ Perforation (1987); Thrombosis (2100); Blood Loss (2597); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It is alleged that the plaintiff received a gunther filter on (b)(6) 2008. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(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 11may2018 as follows: pt allegedly received an implant on (b)(6) 2008 via the right femoral vein due to current combination deep venous thrombosis, pulmonary embolism and gi bleed. Pt is alleging vena cava perforation, device is unable to be retrieved, bleeding, organ perforation and vertebral body perforation. Pt. Further alleges bleeding, anxiety, mental anguish, stress and deep vein thromboses after implant. There have been no reported attempts at filter retrieval.
 
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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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7524638
MDR Text Key108605298
Report Number1820334-2018-01498
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIGTCFS-65-FEM
Device Lot NumberUNKNOWN
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 Received02/24/2020
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: 05/17/2018 Patient Sequence Number: 1
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