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 Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: the filter was difficult to deploy but eventually 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

Manufacturers ref# (b)(4).Summary of investigational findings: two filters were very difficult to release ¿ logged under (b)(4) (report reference# 3002808486-2020-00762) and (b)(4).Finally, the filter released with no reported harm to the patient.Only one jugular introducer inside an introducer sheath was returned (unknown from which procedure) and kinks were noted next to the hub as well as 108mm from the distal tip.No non-conformances were noted on the distal sheath tip.After removal from the introducer sheath kinks were noted on the protection sheath 100mm and 114mm from the distal tip and another squeezed/accordioned area was noted 656mm from same.The red safety button was pressed down, ie the system was unlocked, but when pressing the blue release button, it did not spring back to starting position and the grasping hook did not move inside.After cutting open the protection sheath no non-conformances were noted inside the handle or in the safety button, but the jugular introducer inside had fractured.Based on the limited information provided the exact reason for the fracture cannot be determined and a detailed analysis by scanning electron microscope revealed no sign of inclusion.However, where fractured the introducer was bent perpendicular to the length and cracks were noted near the fracture, thus suggesting that external forces caused it.No evidence to suggest product was not manufactured according to specifications.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.

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: 10739788
• MDR Text Key: 213180926
• Report Number: 3002808486-2020-00992
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)230303(10)E3959092
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/03/2023
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E3959092
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 69