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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 Bent (1059); Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2012
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: introducer system, dilators, and sheath returned in the tray. Found introducer system nice and straight except from a minor bend in the middle. Locking mechanism was unlocked. Introducer and grasping hook manufactured according to specifications and working as intended. The damaged filter leg may be due to reported rotation, and the filter not expanding in the first place may be due to a clot turning into fibrin formation or due to other biochemical mechanism during the procedure. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: ivc filter placement was performed. When the physician withdrew the sheath, the filter was not expanded. The filter was retracted into the sheath and the delivery catheter was rotated once. Then the sheath was withdrawn again and the filter was expanded adequately. The position was confirmed and the filter was released. At that point, it was observed the secondary leg was damaged and turned outward. The physician attempted to remove the filter with a gooseneck snare, however it was not retracted due to the tuned filter although the filter hook was caught with the snare. The procedure was completed because there did not seem to be any better way to treat this. Patient outcome: the patient is fine.
 
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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 Key6292213
MDR Text Key66225361
Report Number3002808486-2017-00208
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 03/09/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2017
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 Received03/09/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2011
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: 02/01/2017 Patient Sequence Number: 1
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