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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 Occlusion Within Device (1423); Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Thrombus (2101); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a cook günther tulip filter. Expiration date: unknown as lot# is unknown. (b)(4). 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) 2010. " 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). Catalog#: unknown but referred to as a cook günther tulip filter. (b)(4). It has not been possible to investigate or evaluate this alleged 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.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2010. " 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). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
Additional information provided 02/22/2017 - patient alleges that filter was placed (b)(6) 2010 for the prevention of dvt. No attempts have been made to remove filter. The 2015 medical records indicate that ivc appears to be occluded below the level of renal veins. Patient alleges that device is unable to be retrieved, filter/ivc is occluded and post implant blood clot.
 
Manufacturer Narrative
Additional information provided determined that this device was manufactured by cook inc. With the submission of this follow up report, william cook (b)(4) informs that this complaint has been transferred from william cook (b)(4) to cook inc.
 
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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 Contact
marianne hoey
sandet 6
bjaeverskov 4632, IN 47404
8123392235
MDR Report Key5982392
MDR Text Key55782965
Report Number3002808486-2016-01162
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeTX
PMA/PMN Number
K090140
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 05/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received02/22/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/06/2010
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: 09/28/2016 Patient Sequence Number: 1
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