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

Model Number G34309

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: team leader.Pma/510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "physician experienced difficulty deploying"."the patient suffered no adverse effects from the filter.This was just a more difficult deployment of the cook celect platinum jugular ivc filter.Filter was deployed eventually.The rep has came in and gave a instructional on the device to the doctor that had the incidence.Filter was deployed eventually".Event date unknown.Patient outcome: patient did not experience any adverse effects due to this occurrence.

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: the customer experienced a difficult deployment.The filter was deployed eventually.The patient suffered no adverse effects from the filter.Jugular introducer with protection sheath, introducer sheath, introducer dilator and stop cock were provided for product evaluation.Blood/biological matter was present.At first, it was not possible to get the grasping hook out because of hardened blood/contrast material.After some time, the function was obtained and no nonconformances could be found.It was possible to attach and release a celect-pt filter.Per the product evaluation, the likely cause for the reported event could be hardened blood/contrast or excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Review of device history record showed no evidence to suggest that the device was not manufactured according to specification.According to instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Based on the provided information and product evaluation a likely cause is that tension made it difficult to release the filter.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 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: 9265461
• MDR Text Key: 202366234
• Report Number: 3002808486-2019-01791
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)220625(10)E3868341
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2022
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3868341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1