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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); Migration or Expulsion of Device (1395)
Patient Problem Thrombus (2101)
Event Date 12/16/2013
Event Type  No Answer Provided  
Manufacturer Narrative
(b)(4). Catalog #: igtcfs-65-jp-jug-tulip. Similar to device under 510(k) (b)(4). (b)(4). Summary of investigational findings: nothing in the investigation on the returned introducer revealed a device failure. During investigation it was noted that grasping hook was deformed in shape. This deformation is most likely due to the physician trying to resheath the filter inside the sheath by pulling the introducer although resistance was felt, resulting in deformed grasping hook and the detached filter. However, the filter would not deploy from the introducer during the procedure and this caused the resheathing attempt. It is seen before that to much bach tension while release button was pushed could cause deployment difficulties/failure when release button was pushed. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: on (b)(6) 2013: ivc filter placement was performed. The introducer sheath was approached via the right internal jugular vein and position of the renal veins and presence of thrombosis was verified by angiography. After that, the sheath was advanced a little without a wire guide. Then filter placement was attempted without performing an angiography. However, the filter would not deploy, so the physician attempted to resheath the filter but resistance was felt. When the sheath covered about a half of the filter, the filter hook disconnected from the introducer. The filter was re-connected to the introducer and resheathed. Then it was once freed out of the sheath to perform an angiography but the filter anchor was found to have migrated in the right ovarian vein. The physician stopped using the device and used another one for the procedure. Patient outcome: no adverse effect to the patient.
 
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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 Key6272084
MDR Text Key65566349
Report Number3002808486-2017-00051
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 12/18/2013
1 Device was Involved in the Event
0 Patients were 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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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