• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FEMORAL APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JP-FEM-TULIP
Device Problems Difficult or Delayed Positioning (1157); Retraction Problem (1536)
Patient Problem No Code Available (3191)
Event Date 12/24/2014
Event Type  No Answer Provided  
Manufacturer Narrative
(b)(4). Catalog #: igtcfs-65-jp-fem-tulip. Similar to device under 510(k) k090140. Summary of investigational findings: investigation evaluation confirms that the physician could not release the filter from the femoral introducer and it was confirmed that 80% of the filter was re-sheathed. However, the degree af re-sheathing offers no insight on why the filter legs did not release/deploy from filter introducer. Investigation of returned device showed no difficulties during simulated deployment test on the table. Filter expanded after release and no evidence was found to suggest that device was not manufactured according to specifications. The exact root cause for the difficulties experienced remains unknown. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: on (b)(6) 2014: a female with pulmonary thromboembolism underwent ivc filter placement by right femoral approach. The sheath system and the filter introducer of the complaint product were advanced from right femoral vein and deployment of the filter was attempted. However, although the physician pulled the red hub backward enough to contact the pinvise, the legs of the filter would not expand and the filter could not be released. Therefore, he tried to retract the filter back into the sheath, but the secondary legs got deformed (pulled up to the filter hook) during that attempt and due to the deformation, when only 4/5 of the filter was pulled back into the sheath, the filter got stuck at the tip of the sheath and became impossible to withdraw back further. The physician pulled back the sheath to the common femoral vein under that condition (filter was stuck at the tip and 1/5 of the filter was still extending out of sheath) and tried to retrieve it out of the body, but as the patient complained pain, retrieval was given up. The sheath system and the filter introducer still with filter were remained in the body as they were determined to be retrieved by surgical operation the next day. On (b)(6) 2014: the sheath system and the filter introducer were retrieved successfully by surgical operation as planned. Although blood transfusion was conducted as the amount of bleeding after the operation was large, there seemed to be no threat to the patient's life. Patient outcome: on (b)(6) 2014: although monitoring is necessary, there seems to be no threat to the patient's life.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGÜNTHER TULIP VENA CAVA FEMORAL 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 Key6272085
MDR Text Key65565581
Report Number3002808486-2017-00034
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 12/24/2014
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-FEM-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 Received12/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2014
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
-
-