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 Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
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.

• 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
• MDR Report Key: 16328952
• Report Number: 3005580113-2023-00021
• Device Sequence Number: 8098761
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2023
• Report Date (Section F): 02/07/2023

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?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2023
• 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