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

Model Number G52916

Device Problem Difficult or Delayed Activation (2577)

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

Event Type  malfunction  

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 the filter did not release easily.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.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 an exact cause cannot be established.However, excessive tension during deployment may have prevented the filter from being released easily.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: 11981321
• MDR Text Key: 256033800
• Report Number: 3002808486-2021-01341
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)240507(10)E4107878
• 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

• Date FDA Received: 06/11/2021
• 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
• Device Lot Number: E4107878
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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