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

Model Number G34505

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Pma/510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a patient of undisclosed age and gender underwent a filter placement procedure in which the cook select platinum navalign uniset vena cava filter set, g34505, was used.The filter did not deploy completely in the patient.Filter was placed femoral.Physician said he did everything correctly as in times past.Denied any twisting or torquing of the device.Dr said that device appeared normal prior to deployment.Dr denied any weird filling in the deployment of the handle prior to and after deployment.Filter was manipulated trying to free up the legs, then retrieved via jugular approach and another filter was then placed also via jugular approach with no hiccups.Once the filter was extracted it opened up perfectly outside of the body.Patient outcome: unknown.

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).Summary of investigational findings: during placement from femoral approach the filter did not deploy completely inside the patient.Since reported that the filter ¿opened up perfectly outside the body¿, it is assumed that the filter released from the femoral introducer, but did not fully expand.The filter was removed and replaced from jugular approach with no adverse effect to the patient reported.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.Only the celect-pt filter was returned and biological matter was present.A thorough investigation did not reveal any non-conformances and any measurements and diagonal distances of the filter were found according to specifications.Only, it was noticed that when placing the filter on a table in an upright position, one of the primary filter legs did not touch the table, but still the filter was properly shaped and fully expanded.Based on these findings the exact reason for the filter to not expand cannot be determined, but it is previously seen that filter legs may be somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if the filter is not placed in ivc.However, this is only speculation since no imaging was provided.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.

Manufacturer Narrative

Manufacturers ref# (b)(4).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

Additional information received on 06jul2020: the physician was able to retrieve the device all okay from the jugular side.Then placed a filter via jugular approach with no further complications.

• 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
• MDR Report Key: 10183148
• MDR Text Key: 202359563
• Report Number: 3002808486-2020-00638
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)210207(10)E3686896
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2021
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3686896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention