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	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: the physician placed filter, no deviation from how he always places them, from the right femoral vein approach.Message was that the red ¿lock¿ on the ivc filter wasn¿t working properly.The filter would not deploy and then it ended up deploying in the sheath.They tried to resheath it since it was only partially out of the sheath, however that just messed the secondary struts up.Ultimately, the physician got internal jugular access and had to snare the sheath to hold it in place while the tech slowly retracted the deployment sheath.

• 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: 15159101
• Report Number: 3005580113-2022-00087
• Device Sequence Number: 12199485
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)250218(10)E4225464
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/03/2022
• Report Date (Section F): 08/03/2022

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: 02/18/2025
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E4225464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2022
• Date Device Manufactured: 02/18/2022
• 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: 08/03/2022