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 Activation (2577); Insufficient Information (3190)

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref#: (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Pma/510(k): k172557.Investigation is still in progress.

Event Description

According to the initial reporter: upon deployment of the filter the release button jammed within the handle, it seemed like it was permanently depressed or sank within the handle but the filter was still able to deploy.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 upon deployment of the filter the release button jammed within the handle.It seemed like it was permanently depressed within the handle, but the filter was still able to be deployed.The jugular introducer inside the sheath was returned with the three-way stopcock.Sheath and introducer were curved and the handles were not properly connected.On the introducer the release button was ¿permanently depressed¿ as reported and the grasping hook stuck outside the distal tip, but was found according to specifications.Consequently, the introducer handle was opened and an investigation found the spring inside sticking due to hardened blood and revealed a kink in the introducer in the most distal part of the handle.After soaked in water the spring moved freely and worked as intended.No evidence to suggest that the device is not manufactured according to specification.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.Based on the product evaluation the exact reason for the difficult filter release cannot be determined.However, according to the instructions for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated, or the hardened blood found in the handle may have prevented the grasping hook from moving freely.Following, repeated attempts to release the filter may have caused the cannula to kink.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 & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11981652
• MDR Text Key: 256245038
• Report Number: 3002808486-2021-01342
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)240113(10)E4060787
• 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: 07/29/2021

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: No Information
• Device Expiration Date: 01/13/2024
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E4060787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1