MAUDE Adverse Event Report: WILLIAM COOK EUROPE APS 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	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: inferior vena cava (ivc) filter deployment was unsuccessful.Two retrieval sets were utilized to remove the filter.A new access site was established, and a second device of the same type was successfully deployed to complete the procedure.Patient outcome: delay with unknown of the lenght of time.What was the indication for filter placement? pe prevention.If known, how long was the filer implanted in the patient? few minutes.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE APS; sandet 6; bjaeverskov
• MDR Report Key: 23096241
• Report Number: 3005580113-2025-00048
• Device Sequence Number: 8685684
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)280630(10)E4724070
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2025
• Report Date (Section F): 09/19/2025

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: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E4724070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/28/2025
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/19/2025