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); Activation Problem (4042)

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

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: ivc filter was positioned and placed with hook just below the renals and centered in the ivc.The safety button was pushed and the filter would not release from the hook when the blue button was pushed.It took a few pushes to disengage the filter from the hook which tilted the filter with hook against the wall of the ivc.Physician had to use retrieval device to reposition and center the ivc filter.Patient outcome: the ivc filter was repositioned in optimal position for retrieval at a later date.Physician had to use a retrieval device ((b)(4)).According to the initial reporter, the 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

Manufacturer ref# (b)(4).Summary of investigational findings: per the complaint report the ivc filter would not release from the hook after the safety button was pushed.It took several pushes to disengage the filter, which in turn tilted.On the image submitted for review, a leftward tilt of approximately 11° is noted and the hook appeared to be resting against the wall of the ivc.The deploying physician used a retrieval device to reposition the ivc filter in the center of the ivc.No patient harm reported.No product was returned for device failure analysis but per the ifu a possible reason for 'difficulty with releasing hook' is the failure to use 'slight back tension' during filter deployment.If 'excessive' back tension is applied, the ivc filter hook will not be released.There is no comment made in the complaint report regarding any back tension applied during point of deployment.No evidence to suggest the product was not manufactured according to current 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.

• 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: 8495055
• MDR Text Key: 145641425
• Report Number: 3002808486-2019-00412
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)220204(10)E3820021
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2022
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3820021
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/27/2019
• Device Age: 2 MO
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR