MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52916

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).Pma/510(k): k172557.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "both devices were successfully implanted.Unknown to the dm for sure, but believed to have been involved in separate procedures.Both devices had problems with deployment/detachment.Lab manager was unsure about how they had difficulties, except that it was when they pushed the release buttons." additional information received on 13mar2020: the devices were involved in separate procedures.Patient outcome: no adverse effects was reported on the patient due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: during procedure customer had trouble in the deployment of the filter.The difficulty was when they pushed the release button.The procedure ended successfully.There are adequate controls in place to ensure the device was manufactured to specifications.According to the instruction for use excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Based on the provided information it is unknown if the red safety button was pushed down before the release button was pushed down.Furthermore a likely cause is that excessive tension prevented the filter from being released.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.

Event Description

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

• Brand Name: GUNTHER TULIP 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: 9879495
• MDR Text Key: 202368164
• Report Number: 3002808486-2020-00362
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)221120(10)E3924012
• Combination Product (y/n): N
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E3924012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1