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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 Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Blood Loss (2597); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Catalog #: unknown but referred to as a cook günther tulip filter. Expiration date: unknown as lot # is unknown. (b)(4). Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. Mfr date unknown as lot# is unknown. Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2015. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). 510(k) k072240. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 04/27/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the right femoral vein due to left common femoral vein dvt and pe. Plaintiff is alleging device is unable to be retrieved and bleeding.
 
Manufacturer Narrative
(b)(4).
 
Event Description
(b)(4).
 
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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 Contact
marianne hoey
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key6529017
MDR Text Key73898125
Report Number3002808486-2017-01025
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 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIGTCFS-65-UNI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/19/2017
Event Location No Information
Date Manufacturer Received04/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/16/2014
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: 04/28/2017 Patient Sequence Number: 1
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