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

Model Number	G52918
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to the initial reporter: a patient underwent an ivc filter placement procedure in where a gunther tulip vena cava filter was placed, access achieved via right groin.The tech asked the district manager if the filter would deploy without pushing the red button.District manager advised the red button had to be pushed.When removing the filter it was noted that the filter did not fully deploy.The filter was re-sheathed and went over all of filter except the hook.When trying to remove the hook got caught on the filter.The physician cut the device outside of the patient with wire cutters.Then used an 11fr sheath, unknown manufacture, and was able to cover the hook and removed successfully.Sutured up the right groin.Used a celect uni filter on left side to complete the procedure.Patient outcome: no additional information regarding the patients outcome has been received.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & 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: 12955234
• Report Number: 3005580113-2021-00148
• Device Sequence Number: 19912603
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)241001(10)E4166147
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/07/2021
• Report Date (Section F): 12/07/2021

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: 10/01/2024
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E4166147
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2021
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2021
• Date Device Manufactured: 10/01/2021
• 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
• Date Report Sent to FDA: 12/07/2021