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

Model Number G34502

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2023

Event Type  Injury  

Event 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
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 16494733
• MDR Text Key: 310783277
• Report Number: 3005580113-2023-00033
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)251215(10)E4347528
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2023,03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female