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

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

(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.

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.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK 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 Key: 6799821
• MDR Text Key: 83313628
• Report Number: 3002808486-2017-01633
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)191005(10)E3502924
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/25/2017
• Device Age: 9 MO
• Date Manufacturer Received: 11/10/2017
• Date Device Manufactured: 10/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR