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	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, the doctor stated that the filter jumped out of the sheath.The doctor did not feel the tactile bump on the delivery system that should have alerted him to pause the advancement.The doctor tried to re-sheath the filter.The secondary legs were bent pointing toward the patient's head.The filter had not been released from the delivery system but could not be re-sheathed.They tried to retrieve it but could not get the clover snare to capture the hook.The doctor used grasper forceps to grasp the filter and advance a 16 fr sheath over the filter to retrieve it.As the sheath covered the secondary legs, the grasper released the filter and the sheath came off.The legs then straightened out to the normal position.The doctor proceeded to deploy the filter successfully.This problem did extend the time required to complete the procedure to around 4 hours.The rep was called in after the initial deployment attempt.

• 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: 16494733
• Report Number: 3005580113-2023-00033
• Device Sequence Number: 17733995
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)251215(10)E4347528
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2023
• Report Date (Section F): 03/06/2023

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: 12/15/2025
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E4347528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2023
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2023
• Date Device Manufactured: 12/15/2022
• 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: Female