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

Model Number	G52917
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Occupation: lab manager.Pma/510(k) k211874.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: upon deployment of filter, when it was unsheathed it did not expand in normal fashion.Therefore, the filter was re-sheathed and removed from the patient.The physician was able to deploy the filter outside the body (not inside the patient).The physician elected to open and use a filter (from another manufacturer) to complete the intended procedure successfully." 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.
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).Summary of investigational findings: filter did not expand in normal fashion.The filter was removed, and competitor device was used instead to complete the procedure successfully.The filter was returned for evaluation.The filter was returned in expanded position and no non-conformances were found on the returned filter.The cause for the reported failure cannot be determined, based on the device evaluation.Based on the provided information and the returned filter it is assumed that the filter was deployed, and it was observed that the filter legs did not expand as intended.Based on the provided information it is unknown what caused the filter to be unable to expand.However, it is previously seen that the filter legs may be somehow obstructed from fully expanding if the filter is deployed in a thrombus, or the filter legs are caught in a clot, and ¿failure of filter expansion/incomplete expansion¿ is listed in the instructions for use as a potential adverse event.No evidence to suggest that the 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.

• Brand Name: GUNTHER TULIP NAVALIGN FEMORAL 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 16263037
• Report Number: 3002808486-2023-00032
• Device Sequence Number: 6053711
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)241215(10)E4199844
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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: 12/15/2024
• Device Model Number: G52917
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E4199844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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