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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 Pulmonary Embolism (1498); Death (1802)
Event Type  Death  
Manufacturer Narrative
Manufacturer ref# (b)(4). Catalog# is unknown but referred to as cook gunther tulip filter. Reporter occupation: non-healthcare professional. Pma/510(k) k172557. Summary of investigational findings: the reported allegations have been investigated based on the information provided to date. Unknown if the reported death is directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2013. Patient outcome: patient is deceased.
 
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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 (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key9479594
MDR Text Key171563901
Report Number3002808486-2019-01983
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
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2016
Device Catalogue NumberIGTCFS-65-1-FEM-TULIP
Device Lot NumberE3053143
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 Received01/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
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: 12/17/2019 Patient Sequence Number: 1
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