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 Difficult to Fold, Unfold or Collapse (1254); Difficult or Delayed Activation (2577)

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

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Similar to device under pma/510(k) k211875.Investigation is still in progress.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.

Event Description

Description of event according to initial reporter: femoral vein approach, after the release of the filter, the middle main leg of the filter was stuck in the lumen of the delivery sheath and could not be completely released, and the delivery system could not be withdrawn.After using many methods, the doctor finally cut the connection between the handle and the delivery rod and withdrew the delivery system.A filter retriever was placed from the patient's jugular vein, and the rod of the filter was retrieved along with the filter.Patient outcome: the procedure was successfully completed by replaced a new filter.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: after the release of the filter, the middle main leg of the filter was stuck in the lumen of the delivery sheath and could not be completely released.The delivery system could not be withdrawn.After using many methods, the doctor finally cut the connection between the handle and the delivery rod and withdrew the delivery system.A filter retriever was placed from the patient's jugular vein, and the rod of the filter was retrieved along with the filter.The procedure was successfully completed with another filter.Three photos were provided for the investigation.First photo shows the femoral handle without the blue release button and attempted to be separated from the introducer.Second photo shows the filter and the piston removed from the femoral cup.The filter is inside the femoral cup and the piston is next to the femoral cup and filter.The third a final photo shows what appears to be right after the filter had been retrieved.Set 1 containing a jugular introducer, coaxial introducer system, a wire set and set 2 containing a jugular introducer, femoral introducer, dilator, filter, coaxial retrieval set, three non-cook wires and two 5f.038 catheters were returned for evaluation.Set 1: blood and biological matter were present on the returned device.The dilator was observed without nonconformances.The introducer sheath was returned curved.The jugular introducer was without any nonconformances.Set 2: blood and biological matter were present on the returned device.Jugular introducer was returned curved but without nonconformances on the grasping hook.The dilator was returned curved.The femoral introducer was returned without the handle and was separated.The cup was without nonconformances.The fractured end where the handle should have been seems to have been torn apart.A lot of blood was present on the piston, and it was washed and cleaned.Indentation/frays was observed on the piston.The filter was observed with some legs out of shape.The cause for the reported failure cannot be determined, based on the device evaluation.Based on the photo provided it is unknown why the release button on the femoral handle was removed and why the piston was separated from the cup.However, based on the provided information it seems that the filter was released inside the introducer sheath and prevented the filter from being placed correctly, which led to the difficulty encountered.The ifu specify how to connect the introducer sheath hub and femoral introducer handle to ensure the femoral cup is completely free of the introducer sheath before filter release.There are adequate controls in place to ensure the device was manufactured to specifications.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.

Event Description

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

• 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 16002085
• MDR Text Key: 305684757
• Report Number: 3002808486-2022-01055
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002355818
• UDI-Public: (01)10827002355818(17)240614(10)E4124011
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2024
• Device Catalogue Number: IGTCFS-65-2-UNI-FT-CELECT-PT
• Device Lot Number: E4124011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• 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 Age: 71 YR
• Patient Sex: Male