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 Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).G4) similar to device marketed under pma/510(k) k233680.Summary of investigational findings: the tulip filter would not expand and was retrieved with jugular introducer.The procedure was rescheduled.The device was not returned for analysis and no imaging or additional information could be obtained.Therefore, based on the information provided only it would be inappropriate to speculate at what may or may not have caused the filter to not fully expand during deployment, but the filter legs may be somehow obstructed from fully expanding if the filter is deployed in a thrombus, or if the filter legs are caught in a clot.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 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 or Problem Description
Description of event according to initial reporter: when the inferior vena cava was accessed from the jugular vein for ivc filter placement, the filter failed to expand, so the filter was returned into the sheath and abandoned filter placement.As there was no replacement device available on the day, the procedure was rescheduled.Patient outcome: no adverse effect on the patient has been reported.

• 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: 20680641
• Report Number: 3002808486-2024-00241
• Device Sequence Number: 12622539
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)270923(10)E4602871
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: E4602871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2024
• 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