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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 Problem Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2013
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-jp-jug-tulip. Similar to device under 510(k) (b)(4). (b)(4). Summary of investigational findings: no problem is found on delivery catheter. The introducer functions as intended and the grasping hook is compared to an approved grasping hook. No deviation to the approved grasping hook is found. Furthermore, the grasping hook is capable to catch and release a filter. The root cause for this event can not be found based on the returned introducer. An image showing a string-like thing attached on the grasping hook is added in the complaint. Sales rep has noted this comment, "it seems that the inner wall of sheath lumen damaged and became like a string during insertion of the filter". However, investigation of the returned introducer did not reveal any sheath damages or string on the grasping hook. During the investigation of the grasping hook, it was found that grasping hook was contaminated. However, it was found to be blood which easily could be rinsed of with a little water. It is possible that the physician when " he advanced the sheath over the filter hook and pushed the button while pressing the sheath against the joint, then the filter released" means, that the physician has advanced filter delivery catheter beyond the marker on the sheath and until tuohy-borst sidearm adapter reach the distal part of the handle. However, manufacturing documentations does not indicate any nonconformities to specifications neither on the filter delivery catheter or the sheath. Furthermore, according to specifications it is 100 % controlled that the tip is visible when gtcfi-65-jp-jug is inside rs8. 5p-65-rb-gtcf and the proximal part of the tuohy-adapter sidearm adaptor reaches the marker on the filter delivery catheter. Based on the description and the investigation of the product, it is not possible to find the exact root cause why the filter would not release, but excessive tension may have resulted in deployment difficulties/failure when pressing the release button. Cook medical will continue to monitor for similar events.
 
Event Description
Ivc filter placement was performed on (b)(6) 2013. A 8. 5 fr. Sheath was advanced through the right jugular vein and placed below the renal vein. When the physician pushed the metal button as per the ifu, the filter did not release. He advanced the sheath over the filter hook and pushed the button while pressing the sheath against the joint, then the filter released. 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 Key6272086
MDR Text Key65570743
Report Number3002808486-2017-00047
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 10/24/2013
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? Yes
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 Received10/25/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2013
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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