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); Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device under pma/510(k) k211874.Investigation is still in progress.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: igtcfs-65-1-jug-tulip was attempted to be placed at inferior vena cava filter approached from right jugular, but it deployed tilted.The user pushed the filter back in the sheath and attempted to deploy it, but the filter legs didn't deploy precisely.He pushed the filter back in the sheath again and deploy it again, but the filter wouldn't deploy precisely.Therefore he removed igtcfs-65-1-jug-tulip, and used other product of same rpn and changed a placement position to complete the procedure without problem.Patient outcome: no health hazard.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).After investigation the event for this (b)(4) is no longer reportable.Summary of investigational findings: the filter deployed tilted, when placed from jugular approach.Attempts to reposition the filter were unsuccessful, why the device was removed and another device was successfully placed without reported harm to the patient.The dilators, the introducer sheath, the locked jugular introducer and the detached tulip filter were returned.On the filter some biological tissue prevented two primary legs from expanding, but after removing the tissue the legs did fully expand and the filter regained its shape.The returned jugular introducer was still locked, thus suggesting that the tilted filter did not detach from the introducer, but based on the investigation findings the exact reason for the filter to tilt during the attempted placement cannot be determined.The instructions for use supplied with the device specified how to perform diagnostic imaging to verify the position of the introducer sheath tip before removing the dilator and advancing the introducer/filter and following how to verify that the filter is in desired position before expanding and releasing it from the jugular introducer.There are adequate controls in place to ensure that the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before release, there is evidence that the device history record 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 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: lissi walmann ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 16937684
• Report Number: 3002808486-2023-00148
• Device Sequence Number: 12219866
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)260301(10)E4379053
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4379053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown