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 Codes	Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref (b)(4).Occupation: inventional radiology (ir) supervisor.Pma/510(k): k211875.Investigation is still in progress.This report is required by the fda under 21cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event according to initial reporter: upon insertion of the filter, the filter detached from the catheter but would not open.It was retrieved successfully with a clover snare.The procedure was then successfully completed with an internal jugular filter of the same type.The doctor speculated that the filter would not open because of plaque or being inside a dissection plane.He does not think that the device malfunctioned.Patient outcome: the patient did not experience any adverse effects or required additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturer ref#(b)(4).Summary of investigational findings: an 87-year male patient underwent ivc filter placement with an igtcfs-65-1-fem-celect-pt (complaint device) from right femoral approach.During deployment the filter was detached from the catheter but would not open.Therefore, the filter was retrieved successfully with a clover snare and the procedure was then successfully completed with an internal jugular filter of the same type.The doctor speculated that the filter would not open because of plaque or being inside a dissection plane, but no device malfunction was suspected.The device was not returned.A single fluoroscopic image is provided.An imaging review of the provided image is performed by an imaging expert.The images submitted for review shows that neither primary nor the secondary filter legs have expanded.The filter is still in a collapsed configuration similar to that when it is within the deployment sheath.Given the overall configuration of the ivc filter, the image reviewer would agree that the filter was either deployed within potentially thrombus, thrombus formed within the sheath, or the end of the filter inadvertently punctured through the wall of the ivc at some point and this was restricting the filter from expanding.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: henriette s. christiansen ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 17340895
• Report Number: 3002808486-2023-00202
• Device Sequence Number: 17868193
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)260309(10)E4382902
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 03/09/2026
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E4382902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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: 87 YR
• Patient Sex: Male