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

Model Number G34309

Device Problems Malposition of Device (2616); Difficult or Delayed Separation (4044)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: "physician expressed that he has had difficulty with the ivc filter releasing once the red safety button is released in approximately the last five cases.He has to rotate the delivery system for the filter to finally release once the blue button is pushed.All have eventually released but some are tilted in the ivc that are going to make retrieval challenging." patient outcome: device is meant to be left in place in the ivc until no longer medically needed and then will be retrieved with a ivc filter retrieval device.The patient did not require any additional procedures and 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: it was reported that the filter was difficult to release - the delivery system had to be rotated to finally release the filter once the blue button was pushed.No product nor imaging was available for investigation and based on the limited information provided, the exact reason for the difficulties encountered, when attempting to release the filter from the jugular introducer cannot be determined.The instructions for use specifies to press the release button completely and to keep slight back tension on the introducer, when releasing the filter, but it also specifies that excessive back tension applied to the system during attempted filter release may prevent the filter from releasing when the release mechanism is activated.There are adequate controls in place to ensure that this type of device is manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.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 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: 9915116
• MDR Text Key: 203491091
• Report Number: 3002808486-2020-00383
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)191110(10)E3518456
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2019
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3518456
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1