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

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problem Difficult or Delayed Activation (2577)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: approach was gained from the jugular vein and the user tried to deploy the filter but the filter was not deployed.He tried some times to deploy it but failed, so the device was removed outside of the body.Another igtcfs-65-jp-jug-tulip was used instead.There have been no adverse effects to the patient reported.

Event Description

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

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigation findings: the user tried to deploy the filter, but the filter was not deployed.Tried a few times to deploy it but failed, so the device was removed from the patient.Another device was used instead.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.According to instruction for use excessive force should not be used to place the filter.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information an exact cause for the event cannot be established.However, a likely cause is that during filter deployment excessive force prevented the filter from being released.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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: GUNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11341581
• MDR Text Key: 233414494
• Report Number: 3002808486-2021-00128
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002037738
• UDI-Public: (01)10827002037738(17)230623(10)E3991770
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Device Lot Number: E3991770
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1