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	05/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: gained access and took several venograms which were normal.Tried to deploy the filter but when filter was released it failed to open up.While they were preparing jugular access to retrieve filter, the physician prodded the filter with the sheath and it opened up.The hook ended up in the right renal vein.They were unsure whether the filter jumped up to the level of the renals or whether the blood flow carried it up to the renals.They attempted to retrieve the hook by femoral access using the gtrs retrieval kit to pull it out of the renal vein but were unsuccessful.They finished procedure without further incident.No further intervention is planned at this time.The physician is going to consult with patient¿s oncologist regarding his long term prognosis with cancer to determine advisability of attempting filter retrieval at a later date.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 & 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: 11981977
• Report Number: 3005580113-2021-00069
• Device Sequence Number: 4380934
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)220328(10)E3837201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2021
• Report Date (Section F): 06/10/2021

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: 03/28/2022
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E3837201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR