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, Positioning or Separation Problem (2906)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Pma/510(k) k171712.Investigation is still in progress.

Event Description

Filter would not release properly.User had to go back in with a retrieval kit and reposition the filter.Additional information received 26mar2019 from regional manager: "the retrieval device used to reposition the ivc filter that was tilted after deployment"; "the hook was against the wall".The patient did not require any additional procedures due to this occurrence.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: it was reported that the filter was repositioned by retrieval device after a difficult filter release, as the hook was against the wall.A single poor quality image submitted for review demonstrates a celect platinum ivc filter with 16° rightward tilt resulting in the hook abutting the right lateral wall of the ivc.The complaint report states "filter would not release properly".There was no elaboration or description of what was meant by this statement.The ifu for the celect platinum ivc filter states slight back tension needs to be applied to the filter when pressing the release mechanism to allow the filter hook to detach from the deployment mechanism.If excessive back tension is applied, the filter will not release from the detachment hook.If this scenario was encountered, while attempting to release the filter, the physician tried to push the entire device caudally, in attempts to disengage the hook, this action could have resulted in the filter tilt.Unfortunately, without further information regarding the actual difficulties encountered when deploying the ivc filter, this is only speculation.The complaint report also states "the retrieval device used to reposition the ivc filter" suggests the deploying physician retrieved the ivc filter or at least repositioned it in such a way that the filter no longer exhibited a significant tilt.There are no images confirming this statement.There are adequate controls in place to ensure the device was manufactured to specifications.The device history record was reviewed with no evidence to suggest that the device was not manufactured according 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.

• 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: 8495054
• MDR Text Key: 141343891
• Report Number: 3002808486-2019-00402
• 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: 12/05/2019

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?: No
• 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: 03/22/2019
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR