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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 N/A
Device Problem Difficult to Remove (1528)
Patient Problems Pain (1994); Disability (2371)
Event Type  malfunction  
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
Patient allegedly received an implant on (b)(6) 2010 due to pulmonary embolisms and deep vein thrombosis.
 
Manufacturer Narrative
Investigation ¿ investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. Unknown if the reported pain and disability are directly related to the filter and unable to identify a corresponding failure mode at this time. The following allegations have been investigated: pain, disability. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava. Cook will reopen its investigation if further information is received. Product is manufactured, inspected and packaged by william cook (b)(4).
 
Event Description
No additional information provided at this time.
 
Manufacturer Narrative
William cook (b)(4) initially reported event under mfr report # 3002808486-2016-01341. New information was received identifying that the product was a cook inc. Manufactured device. (b)(4). The event is currently under investigation.
 
Event Description
It is alleged that a patient received a gunther tulip filter on (b)(6) 2010. It is alleged that the device is unable to be retrieved without further details. It was reported that the patient experienced pain, suffering and disability.
 
Manufacturer Narrative
According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu. It has not been possible to fully investigate or evaluate this event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
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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 Key6408283
MDR Text Key196346143
Report Number1820334-2017-00572
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 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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 Received06/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/24/2010
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: 03/15/2017 Patient Sequence Number: 1
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