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 Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: physician went to deploy the tulip from the jugular approach as he un-sheathed the filter he noticed the legs did not open up to the diameter of the ivc.He then decided to recapture it.He was able to get the filter halfway into the delivery sheath with the release mechanism broke.The filter was still halfway out the delivery sheath.The physician did not want to remove that way, so he decided to push the filter out of the sheath with a wire.The legs still did not open up.He was able to retrieve the filter using the cloversnare.Once the filter was retrieved it was placed into a specimen cup, the legs then opened up.He then placed an filter form another manufacturer to complete the procedure.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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
• MDR Report Key: 16853584
• Report Number: 3005580113-2023-00049
• Device Sequence Number: 7555718
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)251212(10)E4345769
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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 F): 05/02/2023

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: 12/12/2025
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4345769
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2023
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2023
• Date Device Manufactured: 12/12/2022
• 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: 05/02/2023