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

Catalog Number IGTCFS-65-1-JUG-TULIP

Device Problems Premature Activation (1484); Difficult or Delayed Activation (2577)

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

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k): k172557.Investigation is still in progress.

Event Description

According to the initial reporter: we had an ivc filter case last night.We ended up using 3 kits.On the first kit the filter did not release very easily.When it was released it landed angled.We attempted to reposition but ended up using a snare to remove it.The second filter deployed within the sheath.So everything was removed.Finally the third filter was placed where the physician also experienced the filter not releasing easily.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that during a tulip filter placement the filter would not release easily.It ended up being released in an angled position.It was removed with a snare (b)(4).The second filter was deployed within the sheath.Everything was removed and a new device was used instead and successfully completed the procedure (b)(4).Coaxial introducer system, pre-dilator and the jugular introducer was returned for product evaluation.Per product evaluation: pre-dilator + introducer dilator: no nonconformance observed.Introducer sheath: was returned with a non-cook product in the hub.There was an indentation and frays in the tip.There was no filter inside the sheath, (it was possible to get the introducer dilator through the sheath).Jugular introducer: no nonconformance observed.The red safety button was pressed down.There was some foreign matter at the grasping hook, this was removed by washing with water and a brush, then it was possible to measure the grasping hook.No nonconformance was observed.It was possible to attach and detach a tulip filter at the table.It was not possible to reproduce the failure because the filter was not returned, but it was possible to attach and detach a test tulip filter.The cause for the reported failure cannot be determined, based on the product evaluation, back tension could contribute to the experienced event.It was assessed that because any discovered non-conformances were properly dispositioned before final 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.According to the instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information and product evaluation an exact cause for this event cannot be established.However, excessive tension during deployment may have contributed to event.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
• MDR Report Key: 11973478
• MDR Text Key: 255494746
• Report Number: 3002808486-2021-01329
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention