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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK MEDICAL UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G44155
Device Problem Insufficient Information (3190)
Patient Problems Thrombus (2101); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
Investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion. Therefore, no new investigation activities will be conducted at this time. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Catalog and lot# are unknown, but the tulip filter is manufactured and inspected according to specifications.
 
Event Description
No additional information provided at this time.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
Additional information received on (b)(6) 2017 as follows: [pt] allegedly received an implant on (b)(6) 2014 via the femoral vein due to illio-caval deep vein thrombosis. Pt is alleging bleeding, thrombus present below the vena cava filter, continuous blood clots in the legs. Device retrieval was performed on (b)(6) 2014 due to a large amount of thrombus below the vena cava filter, retrieval was successful. It is alleged that "[pt] received two gunther tulip filters; first filter on (b)(6) 2014 (b)(4) and second filter on (b)(6) 2014 (b)(4) at (b)(6) medical center, (b)(6).
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK MEDICAL
400 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 Key7141168
MDR Text Key260550878
Report Number1820334-2017-04496
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 06/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG44155
Device Catalogue 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 Received05/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2013
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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