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 No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-1-uni-tulip.(b)(4).Investigation is still in progress blank fields on this form indicate the information is unknown or unavailable.(b)(4).

Event Description

Description of event according to initial reporter: the patient was taken to the angiography suite and placed supine on the angiography table.The right neck soft tissues were then prepped and draped in the usual sterile fashion.A timeout procedure was performed to confirm correct patient, correct site and correct procedure.General anesthesia, provided by the anesthesia service, was then started.Next, limited ultrasound examination of the right neck soft tissues was performed and the right internal jugular vein localized.The right internal jugular vein was found to be patent and normal in caliber throughout.An acceptable site for access of the right internal jugular vein was then selected and approximately 5 ml of 1% lidocaine injected into the dermal and subcutaneous soft tissues overlying the selected access to provide local anesthesia.The right internal jugular vein was then used to access the under real-time ultrasound guidance using a 21-gauge micropuncture needle.An image of this was saved and placed in the patient's chart for documentation purposes.Next, a 0.018 inch mandril wire was passed through the micropuncture needle and advanced into the superior vena cava under fluoroscopic guidance.The micropuncture needle was then exchanged over the mandril wire for a 5-french micropuncture sheath and the mandril wire exchanged through the micropuncture sheath for 0.035 inch arnplatz wire.The 5 french micropuncture sheath was then removed and the right neck soft tissue tract and right internal jugular venotomy dilated with an 8-french dilator over the arnplatz wire.An 8.5-french long length ivc filter deployment sheath was then passed over the indwelling amplatz wire and positioned in the inferior infrarenal inferior vena cava under fluoroscopic guidance.A pre-deployment digitally subtracted fluoroscopic/radiographic inferior vena cavogram was then performed.The inferior vena cava was found 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 determined and marked for reference.Next, under fluoroscopic guidance, a retrievable cook gunther tulip ivc filter was then deployed into the infrarenal segment of the inferior vena cava, just inferior to the level of the renal vein confluences.There is difficulty with the release mechanism of the filter on initial deployment resulting in significant tilt of the filter.This was corrected under fluoroscopic guidance using a loop snare.Appropriate final positioning was confirmed with a post­ deployment digitally subtracted fluoroscopic/radiographic inferior vena cavogram.Next, the ivc filter deployment sheath was removed from the right internal jugular vein and hemostasis achieved with direct manual compression.A sterile compressive dressing was then 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.Successful ultrasound and fluoroscopic guided deployment of a retrievable cook gunther tulip ivc filter in the infrarenal segment of the inferior vena cava.Patient outcome: the patient required additional filter repositioning via snare and large caliber sheath due to this occurrence.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: 6799827
• MDR Text Key: 83501187
• Report Number: 3002808486-2017-01634
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)191111(10)E3518920
• 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: 8 MO
• Date Manufacturer Received: 11/10/2017
• Date Device Manufactured: 11/11/2016
• 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: 46 YR