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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 Complete Blockage (1094); Insufficient Information (3190)
Patient Problems Thrombosis (2100); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Catalog number: 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
Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of (b)(4).(b)(4).(b)(6).510(k) k032426.The event is currently under investigation.A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 04/24/2017 as follows: the plaintiff allegedly received the device implant on (b)(6) 2010 due to pe.The plaintiff alleges that this first device, with infrarenal placement, is clotted.
 
Manufacturer Narrative
Additional information provided determined that this device was manufactured by cook inc.With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.
 
Event Description
Additional information provided determined that this device was manufactured by cook inc.With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.
 
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Brand Name
GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key6359999
MDR Text Key68351477
Report Number3002808486-2017-00651
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 07/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-FEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date02/13/2017
Date Manufacturer Received06/22/2017
Date Device Manufactured01/01/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Weight91
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