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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-TULIP
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Blood Loss (2597); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Corrected data: adverse event to product problem, serious injury to malfunction. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'perforation, bleeding, right side retroperitoneal hematoma'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Vena cava wall perforation is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter. There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae. E. G. Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae. In contrast, perforation of adjacent organs is reported with clinical sequelae. 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.
 
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. Name and address for importer site: (b)(4). Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. (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) 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). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 04/18/2017 as follows: the plaintiff allegedly received device implant via right femoral vein on (b)(6) 2015 due to blood clots. The plaintiff alleges bleeding and right side retroperitoneal hematoma after implant of device.
 
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Brand NameGUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6506554
MDR Text Key249336757
Report Number3002808486-2017-00963
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 09/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-1-FEM-TULIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date03/30/2017
Event Location No Information
Date Manufacturer Received09/07/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/23/2015
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: 04/20/2017 Patient Sequence Number: 1
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