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

Model Number G52916

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the patient was started on systemic anticoagulation, but developed gastrointestinal bleeding shortly after its initiation.Therefore; systemic anticoagulation was stopped and interventional radiology consulted for placement of an inferior vena cava filter.The patient was taken to the angiography suite and placed supine on the fluoroscopy table.The right neck was then prepped and draped using aseptic technique.A timeout procedure was then performed to confirm correct patient, correct site and correct procedure.Limited ultrasound examination was performed of the right neck soft tissue in the right internal jugular vein localization.The right internal jugular vein was found be patent and normal in caliber throughout.An appropriate site for access of the right internal jugular vein was then selected and approximately 5 ml of 2% lidocaine were injected into the soft tissues overlying the selected access site to provide local anesthesia.The right internal jugular vein was then accessed under real-time ultrasound guidance using a 21-gauge micropuncture needle.An image of this was saved in place and the patient's chart for documentation purposes.Using standard wire-catheter technique the micropuncture needle was upsized to a 4-french micropuncture sheath over the mandril wire.The mandril wire was then exchanged through the micropuncture sheath for a 0.035 inch bentson wire and the micropuncture sheath exchanged over the bentson wire for a 5-french omni flush catheter.The omni flush catheter was advanced over the bentson wire into the distal infrarenal inferior vena cava under fluoroscopic guidance and a digitally subtracted inferior vena cavogram performed which revealed the inferior vena cava to be patent and appropriate in size for deployment of an inferior vena cava filter.The location of the renal veins and the common iliac vein confluence were also determined at this time.Next, the 5-french omni flush catheter was removed over the bentson wire and the venotomy dilated with a 10-french vascular dilator.An 11-french filter retrieval sheath was advanced into the distal infrarenal segment of the inferior vena cava.A retrievable cook gunther tulip was deployed into the infrarenal segment of the inferior vena cava just below the level of the renal veins with moderate difficulty due to problems with the deployment mechanism.Appropriate positioning and deployment were confirmed with a post-deployment fluoroscopy.The ivc filter deployment sheath was removed from the right internal jugular vein and hemostasis obtained with mild direct manual compression.A dry, sterile dressing was placed over the right neck puncture site.The patient tolerated the procedure well with no complications identified during or immediately following the procedure.The patient left the angiography suite in stable condition and was transferred to the radiology post procedural holding area for close monitoring prior to being transferred back to her inpatient room.Successful ultrasound and fluoroscopy guided deployment of a retrievable cook gunther tulip ivc filter in the infrarenal segment of the inferior vena cava via a right internal jugular vein approach.Patient outcome: 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: investigation is based on event description only.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 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 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: 6799835
• MDR Text Key: 83254985
• Report Number: 3002808486-2017-01632
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)200502(10)E3579834
• 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: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/25/2017
• Device Age: 2 MO
• Date Manufacturer Received: 11/10/2017
• Date Device Manufactured: 05/02/2017
• 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: 78 YR