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

Model Number G52916

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When the physician went to deploy the filter, the legs were stuck together.The physician tried to rotate the whole system and tried to re-sheath the filter and when he re-sheathed the filter, the hook became disengaged from the deployment mechanism and got stuck in the system.The physician removed the whole system and opened up another g52916-igtcfs-65-1-jug-tulip to complete the procedure.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

Correction- the summary report designation is incorrect, the report is not a summary report.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: the filter legs stuck together upon filter release and in an attempt to expand the filter the whole system was rotated and the filter was re-sheathed.However, the filter disengaged from the jugular introducer and stuck in the system.Another filter was successfully placed without further complications to the patient.Only the tulip filter was returned.Some suture-like threads were attached to the filter, but did not prevent the filter from fully expanding and were easily removable.No non-conformances were noted on the filter and the hook as well as any shape, measurement and diagonal distance of the filter legs was within specified requirements.The filter hook was according to specifications, too, and could be grasped by a jugular test introducer and properly loaded and detached without difficulties.Therefore, the exact reason for the filter to not expand cannot be determined, but deployment in a clotted vein may obstruct the filter from fully expanding and the instructions for use contraindicate extensive thrombus in the vein chosen for approach.However, this is only speculation since no imaging was provided and since there is no information of thrombus.Following, the reason for the filter to disengage from the jugular introducer, may be the reported rotation of the system in an attempt to expand the filter, but the instructions for use warn not to rotate the filter inside the introducer system or inside the vena cava as this may compromise filter performance.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.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: 11403075
• MDR Text Key: 234488933
• Report Number: 3002808486-2021-00923
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)240118(10)E4062653
• 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,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2024
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4062653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1