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

Catalog Number	IGTCFS-65-1-JUG-TULIP
Medical Device Problem Codes	Premature Activation (1484); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event according to initial reporter: (b)(6) 2023: after the user deployed the filter, he was attempting to re-sheath the filter, and the filter hook was released from the filter catheter without intention.The filter was inside the catheter sheath at the unintended release, so he removed the whole system with the filter inside from the patient body and ended the procedure.(b)(6) 2023: he conducted another filter placement using another igtcfs-65-1-jug-tulip and placed a filter successfully.Patient outcome: the patient had to be under second filter placement next day.Although the patient is doing fine after the procedure.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Date aware for this event was 26sep2023 at the time is was deemed not reportable however investigation determined 24nov2023 that there was risk for patient harm if it were to recur, and thereby this event became reportable as a malfunction.G4) similar to device under pma/510(k) k211874.Summary of investigational findings: the tulip filter released inside the sheath during attempt to re-sheath it.Another filter was successfully placed.The blue introducer sheath was returned with the jugular introducer and the released filter inside protection sheath.The introducer had kinked 50mm from the handle and introducer/protection sheath had kinked 54mm from the distal tip.Dents were noted in the distal tip of the protection sheath and the grasping hook had slightly straightened.Based on these investigation findings the exact reason for the filter to release inside the protection sheath cannot be determined, but the slightly straightened grasping hook indicates the devices were exposed to manipulation beyond their design during attempts to re-sheath the filter.There are adequate controls in place to ensure that the device is manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before final 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 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.

• 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: henriette s. christiansen ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18259239
• Report Number: 3002808486-2023-00280
• Device Sequence Number: 3904932
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)260523(10)E4409930
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2023

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 Expiration Date: 05/23/2026
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4409930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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
• Patient Sex: Unknown