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 Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Occupation code: non-healthcare professional.Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "when they pressed the button the filter would not deploy.So, the facility jiggled and pressed the button a lot and after several minutes of this, the filter finally deployed." patient outcome: 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.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).Name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).Ec method code: 4116 - incomplete device returned.Ec evaluation code: 4315 - cause not established.Summary of investigational findings: investigation is based on returned product and event description, when they pushed the button the filter did not deploy.The jugulare introducer, the blue sheath and the long dilator have all been returned for investigation.All of which are folded, kinked and intertwined.Based on the product investigation the exact reason for the difficulties encountered cannot be determined.However, the ifu states that excessive back tension could result in deployment difficulties/failure when pressing the release button.It is noted that no patient harm has been reported and the report states, "the facility jiggled and pressed the button a lot and after several minutes of this, the filter finally deployed." there is 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 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: 7717515
• MDR Text Key: 114937196
• Report Number: 3002808486-2018-00827
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)210509(10)E3723676
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3723676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Distributor Facility Aware Date: 07/06/2018
• Device Age: 2 MO
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1