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	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, the filter was placed incorrectly.The lead tech said that the doctor said it misfired.The tech said it was misplaced.They tried to retrieve it but were unsuccessful.The top is in the common and the prongs are in the right internal.They will attempt again to retrieve it within the next few weeks.Additional information received: - was the filter advanced by femoral or jugular introducer? femoral - were the difficulties at deployment due to the handle (blue release button)? not the handle.The filter was not fully introduced.- was the retrieval procedure by using gtrs? the snare was in the retrieval kit.

• 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: 20616003
• Report Number: 3005580113-2024-00076
• Device Sequence Number: 8793034
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)270920(10)E4601867
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/05/2024
• Report Date (Section F): 11/05/2024

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: E4601867
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Date Device Manufactured: 09/20/2024
• 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 Age: 46 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/05/2024