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 Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).Catalog#: igtcfs-65-1-jug-celect-pt (b)(6).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "the filter failed to deploy.A new one was opened and used to complete the procedure".Patient outcome: the patient did not require any additional procedures due to this occurrence.No adverse effects were reported on the patient due to this occurrence.

Event Description

Description of event according to initial reporter: "the filter failed to deploy.A new one was opened and used to complete the procedure".Patient outcome: the patient did not require any additional procedures due to this occurrence.No adverse effects were reported on the patient due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# pr228002.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113 h6) ec method code: 4114 - device not returned ec conclusions code: 4315 - cause not established.Summary of investigational findings: assume "the filter failed to deploy" means the filter would not expand.No product returned and without the actual complaint device, it would be inappropriate to speculate at what may or may not have prevented the filter from expanding.However, it is previously seen that the filter legs may be somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if the filter is not placed in ivc.The physician succesfully removed the filter and the patient was implanted with new filter.No evidence to suggest that this 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: 7559878
• MDR Text Key: 109905630
• Report Number: 3002808486-2018-00653
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)201120(10)E3656483
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2020
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3656483
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/17/2018
• Device Age: 6 MO
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1