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

Model Number	G34309
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref# (b)(4).After investigation was completed on 15apr2025, this event is considered reportable.Summary of investigational findings: the celect-pt filter tilted during placement from jugular approach.The filter was retrieved with a gtrs and another celect-pt filter was successfully placed.The complaint device was not returned and no imaging could be obtained.Therefore, based on the information provided only the exact reason for the filter to tilt during placement cannot be determined.However, it is noted that the filter was retrieved by use of a gtrs without any reported harm to the patient.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.
Event or Problem Description
Description of event according to initial reporter: a 86-year-old female underwent a filter placement procedure in which a g34309-igtcfs-65-1-jug-celect-pt, was used.The filter did not deploy correctly.It was tilted into the wall.A günther tulip vena cava filter retrieval set had to be used to retrieve the filter.The procedure was completed by using another g34309-igtcfs-65-1-jug-celect-pt.Additional information received 10jan2025: the filter was deployed via jugular approach.During implantation procedure difficulties were xtreme tilt but no perforation were encountered.The filter was retrieved with filter retrieval sets and sheaths.They had to use multiple types of retrieval sets.The tilt was observed right after deployment the tilt did evolve during follow up images from the initial implant orientation.Patient outcome: delay, the retrieval and had to do another placement.

• Brand Name: COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• Manufacturer Contact: louise baekmand ; sandet 6; bjaeverskov 4632 ; DK 4632 ; 56868382
• MDR Report Key: 21924293
• Report Number: 3002808486-2025-00084
• Device Sequence Number: 4210444
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)270815(10)E4586481
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E4586481
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female