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

Model Number G52916

Device Problems Off-Label Use (1494); Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: cath lab ir supervisor.Pma/510(k): k172557.Investigation is still in progress.

Event Description

According to initial reporter: placed a jugular ivc tulip filter from the femoral access.The first device advanced and the anatomy was tortuous and had difficult getting filter to the desired location.Once they got the filter there, the delivery catheter was kinked.Tried to detach the filter, but it would not detach because the system was kinked.At this point different access was attempted.Thus, access at the groin was made and a buddy system - a new filter - (same type) was used and it was decided to take it up as a buddy to straighten-out the tortuosity; thereby having a straighter track to the svc; however the physician went to detach the filter (pushing the red and blue safety buttons) and it would not detach from the delivery system.At this point, the physician decided to remove everything from the patient.Upon removal of the second filter system, the filter detached in the iliac vein and it was retrieved with a snare.After everything was removed, the decision was made to abort the case.A follow up procedure was scheduled for the following day and a filter was placed successfully.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient needed an additional procedures due to this occurrence, to place a new filter.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: filter placement in the superior vena cava (svc).A jugular filter was advanced from femoral access and due to tortuous anatomy, it was difficult to get filter to the desired location.Tried to detach the filter, but it would not detach because the system was kinked ((b)(4)).A second jugular tulip filter advanced from femoral approach to straighten the tortuosity failed to detach, to ((b)(4)).Filter detached in iliac vein during removal and was retrieved with a snare.The following day a third filter was successfully placed.No product was returned for investigation and based on the information provided the exact reason, why the filter would not release cannot be determined, but it is noted that the introducer system kinked during advancement through tortuous anatomy and reportedly the kink caused the releasement difficulties encountered.According to the instructions for use the coaxial introducer system must be advanced to the target site and the correct position of the sheath must be established before removing the supporting introducer dilator and advancing the jugular introducer with the loaded filter through the introducer sheath.However, it is noted that the filter was placed in the svc, but according to the instructions for use the tulip filter is intended for percutaneous placement via a jugular vein for filtration of inferior vena cava (ivc) blood to prevent pe.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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 (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12292651
• MDR Text Key: 265570116
• Report Number: 3002808486-2021-01683
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)220528(10)E3858370
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E3858370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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: 71 YR
• Patient Sex: Female