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

Catalog Number	IGTCFS-65-1-UNI-CELECT-PT
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
Event or Problem Description
According to the 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.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.Additional information received 23dec2024: 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.

• 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
• MDR Report Key: 21126761
• Report Number: 3005580113-2025-00003
• Device Sequence Number: 12508156
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2025
• Report Date (Section F): 01/10/2025

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 Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E4585993
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2025
• 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
• Date Report Sent to FDA: 01/10/2025