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

Model Number	G34502
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: a patient of unspecified gender and age underwent an unspecified procedure in which the cook celect platinum navalign femoral vena cava filter set, g34502, was used.When the physician deployed the filter the secondary struts did not open properly.The struts bent backwards.Filter was retrieved and the procedure was completed with a competitors device.Filter was deployed below the lowest renal like intended, access through fem.Filter was placed and immediate retrieval followed.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN FEMORAL 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: 16426133
• Report Number: 3005580113-2023-00030
• Device Sequence Number: 6919174
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)251209(10)E4344988
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2023
• Report Date (Section F): 02/21/2023

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 Expiration Date: 12/09/2025
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E4344988
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/31/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2023
• Date Device Manufactured: 12/09/2022
• 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