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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JP-JUG-TULIP
Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 05/09/2013
Event Type  No Answer Provided  
Manufacturer Narrative
(b)(4). Catalog #:igtcfs-65-jp-jug-tulip. Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: no product was returned for investigation and therefore the exact root cause why the filter did not release from the grasping hook is unknown, but excessive tension may have resulted in deployment difficulties/failure when pressing the release button. Also, no imaging was provided and therefore it would be inappropriate to comment on the unsuccessful filter retrieval due to a huge clot trapped in the filter. Package insert states: excessive tension while releasing the filter may result in a failure to deploy the filter. No evidence to suggest that product was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: the physician attempted to detach the filter with some pulling tension on the delivery system, but the filter would not detach. He then released the pulling tension and the filter could be detached, but it tilted. The filter will be retrieved in 2 weeks. Additional information received 21may2013: on (b)(6) 2013: retrieval of the filter was attempted, but the filter was not retrieved this time because the physician confirmed a huge clot was trapped in the filter. Heparin will be administered for 48 hours and follow-up will be performed on (b)(6) 2013 to determine further treatment. Patient outcome: the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameGÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key6272378
MDR Text Key65571635
Report Number3002808486-2017-00041
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 05/10/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIGTCFS-65-JP-JUG-TULIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2013
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/19/2012
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: 01/24/2017 Patient Sequence Number: 1
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