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

Model Number	G52916
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event according to initial reporter: the inferior vena cava filter did not come off when it was deployed.It was placed back into the sheath and removed.The procedure was completed using another igtcfs-65-1-jug-tulip from the hospital inventory and it was successfully placed.The filter did not come off the introducer hook even when the blue release button was pressed.The filter was deployed in the jugular vein, just below the renal vein.Due to the filter release failure, it was placed back into the sheath and removed.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) pma/510(k): k233680.Summary of investigational findings: when pressing the release button, the filter would not release from the jugular introducer.The filter was re-sheathed and retrieved and another tulip filter was successfully placed.The jugular introducer and the tulip filter were returned.The filter was placed inside the protection sheath, but not attached to the introducer.The filter hook as well as the grasping hook were found according to specifications and the filter could be attached/released without difficulties.A severe indentation was noted in the distal tip of the protection sheath and was likely caused by the filter, if angled prior to release and consequently when re-sheathed.Said angulation may have caused the difficulties in releasing the filter in the first place.The ifu specify to verify correct filter position prior to pressing the release button.There are adequate controls in place to ensure the device was manufactured to specifications.It is assessed that because no non-conformances were detected there is evidence that the device was manufactured in compliance with procedures and according to specifications.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that non-conforming product exists in house or in field.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 NAVALIGN JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 21165822
• Report Number: 3002808486-2025-00008
• Device Sequence Number: 15821414
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)270112(10)E4497043
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4497043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown