MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G34505
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.E3) occupation: lead tech.G4) pma/510(k): k233680.Investigation is still in progress.This report is required by the fda under 21cfr 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 or Problem Description
Description of event according to initial reporter: filter deployment on jug, the deployment release mechanism was getting caught on the filter hook while the physician was trying to release the filter.The procedure was able to be completed by using the device.Due to the event, it caused the filter to tilt, therefore the physician had to use a cook, gtrs-200-rb retrieval set to readjust the filter.There were no issues when releasing from the fem system and loading onto the jug system.Re-sheathing over the filter with the jug system went smoothly.Patient outcome: the physician had to go in with a retrieval set and readjust the filter.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturer¿s ref# (b)(4).Summary of investigational findings: on two occasions the grasping hook caught the filter hook while trying to release the filter from jugular introducer; in one case the filter was successfully placed with no harm to the patient (related complaint) and in one case the filter tilted during the difficult release and was adjusted by use of a gtrs-200-rb (handled in this complaint).The femoral and the jugular introducer were returned.On the jugular introducer the red safety button was not pressed, i.E.The system was still locked, but after unlocking, the grasping hook moved freely and the system worked as intended.During investigation the grasping hook grasped a test filter, and it did not release, even when advancing the protection sheath and collapsing the filter inside.Based on these findings the reason for the reported difficulties in releasing the filter cannot be determined.The still locked jugular introducer may suggest an attempt to release the filter from the locked introducer or that the filter unintendedly released during placement/repositioning ¿ more than the filter being difficult to release, when pressing the release button.The instructions for use supplied with the device specify to push the red safety button to prepare filter release, when the filter position is correct.There are adequate controls in place to ensure the device was manufactured to specifications.It is assessed that because no non-conformances were detected there is evidence that the device was manufactured in compliance with procedures and according to specifications.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that non-conforming 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.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• Manufacturer Contact: louise hauge baekmand ; sandet 6; bjaeverskov 4632 ; DK 4632 ; 56868686
• MDR Report Key: 21136309
• Report Number: 3002808486-2025-00004
• Device Sequence Number: 20705775
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)270814(10)E4585993
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E4585993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown