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 Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "filter deployed without hitting either release or deploy button on handle." patient outcome: patient not harmed.Filter in good place.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).Summary of investigational findings: investigation is based on event description and returned device.It is assumed that the "release or deploy button" should read "safety or release button".The complete device but the filter was returned.On the introducer handle the red safety button was pressed, ie the system was unlocked.During investigation a test filter (e2849234) was repeatedly loaded to and deployed from the jugular introducer and during every attempt the grasping hook was able to easily catch and hold on to the filter until the release button was pressed to release the filter.Based on these findings and the very limited information provided the exact reason for the difficulties encountered cannot be determined, unless the release mechanism was inadvertently pressed after the system was unlocked.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the release mechanism/filter did not perform as intended.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: 8127843
• MDR Text Key: 129457854
• Report Number: 3002808486-2018-01361
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)211005(10)E3781895
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2021
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3781895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Distributor Facility Aware Date: 11/09/2018
• Device Age: 1 MO
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1