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

Catalog Number IGTCFS-65-1-JUG-CELECT-PT

Device Problem Activation Failure (3270)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# pr273854.510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "the first filter deployed, but the legs were wrapped up intertwined (pr273807).They retrieved the filter and tried again with another filter only to have the filter not deploy from the sheath at all (pr273854).They resheathed and started again with a 3rd filter.The third time was fine in the end." patient outcome: the patient did require an additional procedure due to this occurrence: device had to be resheathed and removed for a new device to be placed.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a filter was deployed during a filter placement procedure, but the filter legs were wrapped up intertwined and the filter was therefore retrieved (b)(4).A second attempt to implant a new filter during the procedure failed because the filter would not deploy from the sheath at all.The user re-sheathed the filter and the device was then withdrawn from the patient (b)(4) lastly, the user tried with a third attempt, and the filter was implanted successfully.No adverse effects on the patient was reported due to this occurrence.Two devices with missing parts were returned for evaluation.No parts of the returned product were marked with the belonging pr#.The returned parts belonging to this pr (b)(4) were assumed to be a jugular introducer with a protection sheath and celect-pt filter.When the protection sheath was retracted during the evaluation, it was noticed that the filter was already released.The filter was therefore attached to the grasping hook and the sheath was then advanced over the filter.The sheath was retracted again, and the filter was still attached as expected.A kink was observed on the protection sheath and two of the secondary filter legs were found entangled.However, no visual nonconformances were observed on the hook, and all measurements were in accordance to specifications including measurements of the grasping hook, the filter hook and the filter legs.It is not clear how the procedure progressed prior to attempt of deployment, however, the likely cause for the reported event could be to much back tension during release, as ifu states that excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Furthermore, it is possible that the two secondary filter legs, which was observed to be entangled during the device failure analysis, got intertwined during the procedure.Ifu warns not to rotate the filter inside the introducer system or inside the vena cava as this may compromise filter performance.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.However, 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 JUGULAR 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: 8943809
• MDR Text Key: 157878036
• Report Number: 3002808486-2019-01331
• Device Sequence Number: 1
• Product Code: DTK
• 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
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1