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

Model Number	G34505
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, femoral access, sheath placed to suprarenal ivc, filter loaded but not deployed originally.Once filter loaded into the sheath, as [the physician] was pulling down the sheath to infrarenal location, the sheath got ¿stuck¿ and patient complained of pain.Tried to reposition sheath but the sheath could not be pulled down further.Then the hook of filter was exposed and subsequently filter partially deployed, in suprarenal location.Then [the physician] got ij access and was able to retrieve the filter from suprarenal location.Some fibrinous material was seen around the hook of the filter.Then [the physician] exchanged for a new filter sheath, deployed a new filter in infrarenal location without difficulty.

• 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: 16912443
• Report Number: 3005580113-2023-00060
• Device Sequence Number: 2189007
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)230525(10)E3986132
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2023
• Report Date (Section F): 05/11/2023

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: 05/25/2023
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3986132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2023
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2023
• Date Device Manufactured: 05/25/2020
• 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
• Patient Weight: 87 KG
• Date Report Sent to FDA: 05/11/2023