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

Catalog Number IGTCFS-65-2-UNI-FT-CELECT-PT

Device Problems Component Incompatible (1108); Difficult or Delayed Activation (2577)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

Description of event according to initial reporter: to release the filter through the jugular vein approach, the filter should be inverted first.A problem with the sheath was found during the inversion process and the filter could not be released properly, and a new filter should be replaced immediately.The doctor planned to place the filter through the jugular vein.Opened the filter package and prepare to reload the filter from femoral to jugular introducer.After opening the safety lock, press down the blue button, the filter could not be released from the femoral introducer and after many attempts, the doctor thought that the delivery system had a problem, and a new filter was replaced to complete the procedure.

Manufacturer Narrative

Manufacturers ref# (b)(6).Blank fields on this form indicate the information is unknown or unavailable.G4) 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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturers ref#(b)(4).After investigation the event for this (b)(4) is no longer reportable.Summary of investigational findings: during reload the filter could not be released from the femoral introducer.Another filter was successfully placed.The celect-pt filter, the pre-dilator, the coaxial introducer sheath system, and the femoral introducer were returned.The femoral introducer worked as intended and no non-conformances were noted.On the filter two secondary legs were crossed but easily repositioned, and appropriate personnel were notified of the filter hook, as it was slightly out of specifications.However, the jugular introducer was not returned, but immediately the damaged filter hook had no impact on the filter release from the femoral introducer and therefore the exact reason for the difficulties in reloading the filter from the femoral to the jugular introducer cannot be determined.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 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.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: 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: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18028831
• MDR Text Key: 326840260
• Report Number: 3002808486-2023-00271
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002355818
• UDI-Public: (01)10827002355818(17)260712(10)E4429160
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-FT-CELECT-PT
• Device Lot Number: E4429160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG