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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-JUG-TULIP
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Catalog#: unknown but referred to as a gunther tulip filter. Since catalog# is unknown the 510(k) could be either k090140 or k112119. (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) 2012". 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). Outcomes attributed to device: device unable to be retrieved/difficult to remove (unsuccessful retrieval listed in ifu). The event is currently under investigation. A supplemental report will be provided upon completion.
 
Event Description
This additional information received on 2/14/2017 is as follows: implant date: (b)(6) 2012. Reason for implant: dvt and anticoagulation; gunther tulip cook; unknown lot number; placement physician: dr. (b)(6) hospital. Patient is alleging "device is unable to be retrieved; embedded". Failed retrieval attempt.
 
Manufacturer Narrative
(b)(4). Investigation is reopened due to additional information provided. 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 "device is unable to be retrieved; embedded" cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Difficult filter retrieval due to embedment of filter legs or filter hook in the ivc wall is a well-known risk reported in the published scientific literature. Several case reports published in articles, describe successful endovascular retrievals of such filters by advanced retrieval techniques. 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.
 
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Brand NameGUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6208849
MDR Text Key63412014
Report Number3002808486-2016-01533
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 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-1-JUG-TULIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/06/2016
Event Location No Information
Date Manufacturer Received05/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/28/2016 Patient Sequence Number: 1
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