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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G52918
Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)
Patient Problem Extravasation (1842)
Event Date 07/19/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: no product returned and without the actual complaint device it would be inappropriate to speculate at what may or may not have led to the difficulties in deploying/releasing the filter. However, it is noted that the filter was advanced from jugular approach, ie the filter of the uni device was reloaded from the preloaded femoral introducer to the jugular introducer prior to use. Also, it is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button. The ifu addresses the issue through the statement "while keeping slight back tension on the introducer, push the release button completely to ensure proper release of the filter" and the warning "excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated". No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended. Cook medical will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(4). Catalog# igtcfs-65-1-uni-tulip (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: moderate sedation was administered using versed and fentanyl. The patient was continuously monitored during the procedure by a nurse using automated blood pressure, ekg, and pulse oximetry measurements for approximately 30 minutes. The patient was placed supine on the fluoroscopy table. Ultrasound examination of the right side of the [neck/groin] was performed to confirm patency of the [internal jugular/femoral] vein. Using sterile technique and local anesthesia with ultrasound guidance, the right internal jugular vein was punctured through a small skin incision. Continuous real time ultrasound monitoring of the puncture needle entry into the vein was performed and documented. Under fluoroscopic guidance, a wire was passed centrally through the needle. A catheter was advanced over the wire to the ivc at the confluence of the iliac veins. Ivc-gram was performed. The 12 f filter delivery sheath was advanced into the infrarenal ivc. Multiple attempts were made to deploy the cook retrievable ivc filter, however the filter would not released from the delivery hook. Finally, the filter was able to be released, however the filter was markedly tilted on the placement. Over a wire, the cook retrievable system was advanced and used to grasp the hook in an attempt to reposition the filter. Follow-up venogram demonstrated focal extravasation adjacent to 2 of the filter legs. A wire was advanced beyond the level of extravasation in the indwelling filter was removed. A coda balloon was then advanced over the area of extravasation and inflated for approximately 5 minutes. Follow-up venogram demonstrates complete resolution of extravasation within the ivc with rapid antegrade flow of contrast beyond the previous site of injury. A new filter was advanced over the wire. The filter was deployed in the infrarenal ivc. The sheath was removed, and the puncture site was compressed until hemostasis was achieved. There were no immediate complications, and the patient tolerated the procedure well. Ivc-gram demonstrates normal venous anatomy. There is no thrombus within the ivc. A cook retrievable ivc filter was deployed in the infrarenal ivc. Patient outcome: the patient require additional procedures: balloon occlusion for 5 minutes for extravasation / additional filter placement according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameGUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key6799821
MDR Text Key250902241
Report Number3002808486-2017-01633
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG52918
Device Catalogue NumberIGTCFS-65-1-UNI-TULIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/25/2017
Device Age9 MO
Event Location No Information
Date Manufacturer Received11/10/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/05/2016
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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