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

Model Number G34502

Device Problems Positioning Failure (1158); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Ivc filter did not deploy at the correct time causing it to deploy in an unintended target site.Tried to retrieve the filter but the retrieval was unsuccessful.Another filter was placed successfully.Both filters remain in the patient.Patient outcome: unknown.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: investigation is based on event description only.It was reported that the filter deployed in an unintended target site, since it did not deploy at the correct time (assuming it deployed unintendedly).Filter remained in the patient and a second filter was placed.No harm to the patient reported.No imaging was provided and no additional information could be obtained, but based on the limited information provided, it is assumed that the filter deployed prematurely in an unintended target site.However, the exact reason why the filter deployed unintendedly cannot be determined, unless the femoral introducer was unlocked and the release button was inadvertently pushed before the filter was placed in the correct position, but this is only speculation, since the femoral introducer was not returned.The ifu caution that the filter must be in the correct position before the red safety button is pushed to prepare filter release and then the release button must be pushed completely to ensure proper release of the filter.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.

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 FEMORAL 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: 8494572
• MDR Text Key: 141308988
• Report Number: 3002808486-2019-00399
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)201011(10)E3640546
• 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: 08/05/2019

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3640546
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/21/2019
• Device Age: 17 MO
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention